Statistical Programmer Resume Samples

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R Bechtelar

Rhiannon

Bechtelar

289 Gerhold Courts

Boston

+1 (555) 403 6571

289 Gerhold Courts

Boston

Phone

p +1 (555) 403 6571

Experience Experience

Chicago, IL

Statistical Programmer

Chicago, IL

Lueilwitz Group

Chicago, IL

Statistical Programmer

Receives broad operating instructions in performing a majority of duties from manager and keeps manager abreast of programming status and issues
Serves as a key member of project team by attending team meetings and working with biostatistician data managers and project managers
Assist in determining and developing approaches to technical solutions to ensure process improvement
Provide input into monthly PERFORM forecasts and monitor the completion of forecasted units
Show commitment to and perform consistently high quality work
Helps create or provide training materials in supported area
Perform and plan the development, implementation and validation of new process technologies, macros and applications

San Francisco, CA

Senior Statistical Programmer

San Francisco, CA

Walker LLC

San Francisco, CA

Senior Statistical Programmer

Prioritize personal workload and that of teammates; perform work with minimal supervision
Independently interact directly with Biostatisticians, Data Management, Programmers, and Clinical Development staff and management as the lead programmer
Provide performance evaluation feedback for SAS programmers working on projects
Carry out all activities according to Covance SOPs working within the framework of the Quality management System and to Good Clinical Practice (GCP)
Assists in managing project budgets and tracking project specific performance metrics
Provide reports to Biostatistics management on the status of statistical programs and outputs
Keep management informed of project status in relation to quality, timelines and/or performance issues

present

Los Angeles, CA

Principal Statistical Programmer

Los Angeles, CA

O'Connell-Harris

present

Los Angeles, CA

Principal Statistical Programmer

present

Provide feedback to management on the development potential of staff to assist in staff development
Participate in department working groups; provide input in development of tools and improvement of processes
Carry out all activities according to Sarah Cannon SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP)
Provide programming support for simple presentations and basic statistical ad-hoc requests. Assist in the more complex data presentations
Assist project teams in the resolution of problems encountered in the conduct of their daily work
Create standard macros and applications to improve the efficiency of the department
Review and interpret Statistical Analysis Plans and provide comments for assigned projects

Education Education

Bachelor’s Degree in Computer Science

Arizona State University

Bachelor’s Degree in Computer Science

Skills Skills

Strong knowledge of global clinical trial practices, procedures, development process, and clinical trial data flow, especially in Oncology
Previous pharmaceutical SAS experience
5+ years of experience using SAS in the analysis and reporting of clinical trials data in the pharmaceutical industry
Exceptional communication skills
Working knowledge of database design/structure
Experience in Oncology therapeutic area and CDISC
Strong knowledge of global clinical trial practices, procedures, development process, clinical trial data flow, especially in Oncology
6+ years' experience using SAS in the analysis and reporting of clinical trials data in the pharmaceutical industry
Experience in Oncology therapeutic area / CDISC experience
3 years of experience in the Pharmaceutical Industry

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15 Statistical Programmer resume templates

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Statistical Programmer Resume Examples & Samples

Creates and executes complex SAS programs for commercial products and consulting studies. Utilizes advanced programming languages and techniques for statistical applications development and study delivery
Contributes to the technical design, development and implementation of complex statistical studies
Mentors staff on best practices, presents at technical conferences, participates in technical users groups

Lead Statistical Programmer Resume Examples & Samples

8+ years of Statistical Programming experience with a Bachelor's Degree; 5+ years of Statistical Programming experience with a Master's Degree
Master's / Bachelor's Degree in Computer Statistics, Biostatistics, Biometry, Mathematics, Computer Science or related field or Masters degree in related field
Excellent SAS programming skills including SAS macro development
Knowledge of Base SAS, SAS/STAT and SAS/Graph modules
Understanding of the statistical requirements for Phase 1 through Phase 3 studies
Understanding of CDISC ADaM requirements, understanding of CDISC SDTM requirements
Ability to lead the statistical programming efforts for the generation of clinical study outputs

Senior Statistical Programmer Resume Examples & Samples

30%: Lead Statistical Programmer
25%: Standards Development
Minimum of two (2) years experience in a technical leadership role within a statistical programming organization, preferably in a pharmaceutical, biotechnology or CRO environment
Excellent analytical, technical, and computer skills
Expert programming ability using BASE/SAS, SAS/STAT, SAS MACROS, and SAS/GRAPH
Expert knowledge of CDISC requirements
Advanced knowledge of medical terminology, clinical trial methodologies, and FDA/ICH regulations

Informatics Statistical Programmer Resume Examples & Samples

PhD and 7+ years of experience in the health insurance industry, OR Master’s degree and 12+ years of experience in the health insurance industry
Advanced statistical programming skills in SAS, R, SPSS, or STATA
Expertise in logistic regressions, risk predictions/analyses and additional modeling techniques
Experience with provider analytics around cost and quality, value based initiatives and performance reports for Accountable Care Organization (ACO) initiatives

Statistical Programmer Resume Examples & Samples

Bachelor or Master's Degree in life science, computer science, statistics or equivalent relevant degree
Strong knowledge of global clinical trial practices, procedures, development process, and clinical trial data flow, especially in Oncology
Previous pharmaceutical SAS experience
5+ years of experience using SAS in the analysis and reporting of clinical trials data in the pharmaceutical industry
Working knowledge of database design/structure
Experience in Oncology therapeutic area and CDISC

Senior Statistical Programmer Resume Examples & Samples

Serving as the Lead Programmer for one or more clinical research studies
Producing and/or validating analysis datasets
Producing and/or validating tables, listings and figures
Developing and maintaining standard database and report specifications
Mentoring and training junior Statistical Programmers

Statistical Programmer Resume Examples & Samples

Developing and maintaining standard operating procedures
Developing and maintaining standard applications
Degree and experience in Computer Science, Statistics, or a related quantitative analytical field. At least eight (8) years of industry related (Pharmaceutical, Biotech, CRO) statistical programming experience with a bachelor’s degree or equivalent. At least six (6) years of industry related experience with a master’s degree or above

Statistical Programmer Resume Examples & Samples

Bachelor's or Master's Degree in life science, computer science, statistics or equivalent relevant degree
Strong knowledge of global clinical trial practices, procedures, development process, clinical trial data flow, especially in Oncology
6+ years' experience using SAS in the analysis and reporting of clinical trials data in the pharmaceutical industry
Experience in Oncology therapeutic area / CDISC experience

Principal Statistical Programmer Resume Examples & Samples

Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred
5+ years of experience as a medical writer in the sponsor and/or CRO setting. Experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting is a plus
In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process
Successful track record of managing multiple projects in a fast-paced and deadline-driven environment
Impeccable attention to detail and ability to complete writing assignments in a timely manner with minimal oversight
Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint

Statistical Programmer Resume Examples & Samples

Bachelor's Degree in Mathematics, Statistics or related field
3 years of experience in the Pharmaceutical Industry
Advanced knowledge of SAS and R, including macro/script writing
Expert knowledge in producing graphics using SAS/GRAPH, ggplot or similar
Thorough understanding of CDISC standards, SDTM/ADAM datasets and GCP
Good understanding of clinical databases
Able to manage competing priorities and work on multiple projects
Coding certification
Exposure to PK/PD data, Modeling and Simulation

Statistical Programmer Resume Examples & Samples

Bachelor's Degree in Mathematics, Statistics, Data Analysis Program or Computer Science
2+ years of work experience using SAS in the data review, analysis and/or the reporting of pharmaceutical data
Working knowledge of SDTM database design/structures
Knowledge of other data review/statistics software packages, such as Jreview
SAS software systems experience
Ability to perform effectively in a team environment
Experience in research programming
Knowledge of clinical trials

Statistical Programmer Resume Examples & Samples

Mentoring and training Statistical Programmers
25%: Lead Statistical Programmer
Degree and experience in Computer Science, Statistics, or a related quantitative analytical field. At least seven (7) years of industry related (Pharmaceutical, Biotech, CRO) statistical programming experience with a bachelor’s degree or equivalent. At least five (5) years of industry related experience with a master’s degree or above
Experience in a technical leadership role within a statistical programming organization, preferably in a pharmaceutical, biotechnology or CRO environment

Statistical Programmer / Survey Methodologist Resume Examples & Samples

Develop and maintain SPSS programs designed to manage and analyze multi-level data collected through multi-mode data collection efforts
Lead/serve on project teams comprised of project management, technical, statistical and operations staff
Lead/contribute to technical proposals and other business development activities
Identify improvements in survey processes to reduce cost and/or improve response rates
Evaluate survey outcomes
Analyze complex survey data
Write analytic and methodological reports
Communicate methodological concepts with clients and other project team members verbally and in writing
Work with study team to understand system requirements and programming specifications
Master’s degree required in social policy, survey methodology, or other social science discipline required
Minimum of twleve years’ experience in the survey research field or relevant discipline
Ability to analyze data using SAS and SPSS
Experience in conducting survey research
Ability to conduct multivariate analyses using complex survey data
Strong aptitude for analytic and investigative work
Competent using computer applications and proficient in the use of MS Office products

Senior Statistical Programmer Resume Examples & Samples

Statistics and/or Computer Systems/IT background; Master’s or healthcare degree
Minimum 5 years of statistical programming in a pharmaceutical/biotech or CRO setting
Strong Table, figure, and Listing programming
Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro language
Strong leadership skills and ability to work within cross-functional teams
Excellent interpersonal, organizational, and multi-tasking skills
He/she can effectively design and code SAS applications for multiple clinical projects, consistently meeting objectives of the clinical development program
He/she develops ADaM specifications and SAS codes in support of analysis requirements utilizing CLIENT tools and methodologies and current industry standards

Statistical Programmer Analyst Resume Examples & Samples

Be accountable for development, verification and documentation of SAS code on the assigned clinical project
Will support programming requests in support of clinical trial reporting and submissions
Design and development of statistical programs for the assigned project
Perform quality control in support of clinical R&D analysis and reporting
Maintain documentation as appropriate
Completes programming tasks of low to medium complexity with high quality and timeliness. Works with team to plan and track content, format, quality, and timing of programming deliverables
Identifies and communicates lessons learned with support from team lead
Participates in process, system and tool improvement initiatives
A minimum of a Master’s degree is required in a relevant discipline such as Computer Science, Mathematics or other scientific field
Experience using statistical programming languages and data structures is required
Basic knowledge and experience with SAS programming is preferred
Recent college graduate (must be within 1 year of graduation) or PhD, but we’re also open for candidates with some work experience
Ability to effectively apply knowledge and skills in a complex environment
Good English written and verbal communication
Ability to work in a team environment and independently as needed
Good problem solving and decision making
Good SAS programming skills

Statistical Programmer Resume Examples & Samples

Bachelor or Masters level degree in Biostatistics, Statistics, or a related field
5+ years of pharmaceutical or biotech industry experience
SAS® experience is a requirement
Production of clinical study report deliverables, including analysis datasets, summary tables, figures and listings are relevant qualifications for this position
Experience with regulatory submission, electronic submissions, and relational database is desirable
SAS® Certification is desirable
CDISC training/experience is desirable
Experience with electronic submission formats such as eCTD is desirable
Provide statistical programming representation on project teams - 10%

Senior Statistical Programmer Resume Examples & Samples

Must have the ability to work with limited supervision on multiple assignments
Proficient in SAS programming
Attention to detail in order to provide high quality outputs
Excellent verbal, written and communication skills
Ability to work in a team environment with medical personnel, clinical monitors, data managers, clinical programmers, statisticians, and statistical programmers
Ability to prioritize, multi-task, and maintain attention to detail
Ability to work independently with minimal oversight
Bachelor's degree in Computer Science, Life Science or a related field required
Master's degree in Computer Science, Life Science or a related field preferred

Senior Statistical Programmer Resume Examples & Samples

Under general supervision of the Principal Investigator, applies, researches, and develops statistical models for analysis, inference, and prediction from a variety of large data bases
In collaboration with investigators and trainees, contributes to scientific literature, reports, journals and presentations
Participate as a collaborator in the preparation and dissemination of research findings through presentation and publication in scientific journals
Maintain data security and compliance in adherence to Partners Data and Research computing standards for DUAs, IRBs, Data Storage, etc
Addition database responsibilities include, but are not limited to
Acquire potential data sources and follow-on steps of cleaning, aggregating and importing data from a variety of sources
Analyze data quality and recommendations for remediation of quality issues
Manage reviews of all data includes data collected via surveys and other mechanisms
Preference 2+ years of experience
Strong theoretical statistical background and data analysis skills
Substantial experience applying sophisticated statistical methods to analyze complex datasets
Solid data analysis programming skills using Stata, SAS and/or R
Excellent time management/organizational skills
Excellent written and verbal presentation skills
Ability to work well in a multidisciplinary team setting
High degree of initiative and ability to persevere on challenging research problems
Willingness to seek and accept guidance from senior personnel, as needed

Senior Statistical Programmer Resume Examples & Samples

MS degree in quantitative field such as statistics, operations research, mathematics, or computer science. Strong academic credentials required
Relevant research experience in analysis of complex datasets
Strong theoretical statistics (including Bayesian methods) and mathematics skills
Strong experience applying sophisticated statistical, mathematical, or machine learning methods to analyze complex datasets
Strong programming skills, including in SAS, STATA and/or R
High degree of initiative and ability to persevere on research problems
Follows directions and works with careful attention to detail
Accepts responsibility for assignments, able to prioritize tasks and manage time efficiently
Demonstrates initiative and sound judgment
Maintains a positive working environment and works cooperatively with supervisors and co-workers

Statistical Programmer Analyst Resume Examples & Samples

Applicable work experience includes advanced programming, data management and/or statistical analysis skills
Inquisitiveness, along with the ability to think logically and systematically to analyze and evaluate alternate solutions, is expected
Strong organizational and documentation skills are essential along with the ability to successfully manage multiple tasks with concurrent deadlines
Proven written and oral communication skills along with the ability to work both independently and in a team environment are also essential
A basic knowledge of current medical developments, human physiology, or medical terminology is preferred

Statistical Programmer Analyst Resume Examples & Samples

Some experience or coursework in computer programming or statistical software for data management and statistical analysis is preferred
Strong organizational and documentation skills, proven written and oral communication skills, and the ability to work both independently and in a team environment are essential
A basic knowledge of current medical developments, human physiology, or medical terminology is helpful

Senior Statistical Programmer Resume Examples & Samples

Uses SAS software (BASE, STAT, GRAPH, MACRO) for the production of well formatted datasets, tables,listings, and figures, and outputs requested (e.g., patient profiles) per programming specifications, Statistical Analysis Plan, and other study related documentation
Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework
Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications,annotated CRFs, and SAS database design, and provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities
Participates in sponsor meetings, kickoff meetings, and bid defense meetings as Statistical Programming representative, as required by sponsor
Conducts effective internal meetings appropriate in format, frequency and attendees, distributes relevant information in advance, ensures minutes are promptly and accurately distributed, follows action items through to completion, and maintains order and focus of meeting and works towards consensus
Maintains well organized, complete, and up-to-date project documentation, testing, and validation/quality control documents and programs in compliance with Company and sponsor standards
Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in processes

Senior Statistical Programmer Resume Examples & Samples

Assists in managing project budgets and tracking project specific performance metrics
Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs and SAS database design, providing feedback to the appropriate project team members to reduce inefficiencies in programming activities where appropriate
Academically well qualified: BSc or MSc in Statistics or Medical Statistics
Extensive experience in clinical trials and the drug development process preferably within a CRO and/or Pharmaceutical environment
Ability to apply knowledge of statistical design, analysis and programming techniques used in clinical trials
Strong SAS experience

Senior Statistical Programmer Resume Examples & Samples

Develops specifications and mock-up display for outputs of any complexity according to statistical and sponsor requirement. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework
Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design, and provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities
BS, MS, or equivalent in Mathematics, Statistics, Computer Science, or related field
Extensive experience in SAS programming or equivalent combination of education and experience
Experience with clinical trials preferred

Senior Statistical Programmer Resume Examples & Samples

Make certain that documents and specifications are consistent and comply with company standards by providing input into eCRF and data structures, tables, listings and figures for Phase I-IV clinical trials and submission activities
Program (according to specifications) analysis datasets, pooled datasets, listings, tables, and figures for Phase I-IV clinical trials and for SCS and SCE with high quality and within milestones. Prepare Case Report Tabulations for the submission as required
In consultation with the Biometrician/Statistical Scientist, responsible for development of programming specifications of analysis datasets and pooled datasets
Maintain QC compliance and responsible for trial records including archiving of programming and associated documentation. Responsible for quality control and audit readiness of quality deliverables
Assume the role of subject matter expert / trial domain expert to ensure seamless outsourcing, according to the agreed contract and internal business guidance
Provide support to process improvement initiatives and participate in non-clinical project activities as required
Support/conduct training sessions to programmers on programming standards and Novartis processes/SOPs as required
Contribute to non-clinical initiatives as required

Biostatistician / Statistical Programmer Resume Examples & Samples

Represent the Biometrics function in multi-disciplinary teamwork
May represent the biostatistics function independently in the assigned projects
Create, review, or approve programming and analysis plans and specifications at project and study level
Program, according to specifications, analysis datasets, tables, listings, and figures for clinical trials and publications
Review key study documents produced by other functions (e.g. CRFs, data management plans, clinical study reports, etc.)
Oversee work of outsourcing vendors at study level
Maintain efficient interfaces with internal and external customers and vendors
Must be able to work independently on multiple projects concurrently
Develop or assist in the development of procedures and/or software to transfer data from outside sources, such as CROs or clinical laboratories, to in-house systems
Support quality control of deliverables related to biostatistics
Maintain records for all assigned projects and archiving of trial/project analysis and associated documentation
Contribute to the creation and maintenance of department SOPs related to clinical data analysis

Senior Statistical Programmer Temp Resume Examples & Samples

Bachelor’s degree in Computer Science, Life Science or a related field required
Master’s degree in Computer Science, Life Science or a related field preferred
Minimum of three to five years of relevant experience
Prior experience in the pharmaceutical or biotechnology industries required
Extensive knowledge of SAS programming software required
Knowledge of additional programming languages preferred
CDISC (SDTM and ADaM) experience preferred
Must be able to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Must have a general understanding of regulatory guidelines and their application to data submissions
Must have strong analytical, critical thinking and mathematical skills
Knowledge of SQL and R programming desired
This position requires minimal travel; average travel for this position is 5-10% with some variation based upon the demands of the business imperatives

Principal Statistical Programmer Resume Examples & Samples

Develop and validate technical programming specifications for analysis datasets using Alexion, ADaM or SDTM standards
Independently develop and validate programs that generate analysis datasets based on Alexion, ADaM or SDTM specifications
Develop and validate technical programming specifications for protocol specific efficacy and safety tables, listings, figures/graphs based on Protocol SAP
Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications
Supervise/manage external vendors and contract programmers
Oversee progress of programming activities
Review, maintain, and approve protocol specific documents as necessary
Provide guidance and mentoring to peer and junior-level Programmers
Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies
Contribute ideas and thoughts towards the optimization of standard operating procedures
Lead team meetings, when appropriate
Other activities as assigned and required
Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry
Proven ability to

Biometric Sciences Statistical Programmer Resume Examples & Samples

Some clinical / statistical programming experience related to pharmaceutical clinical development – exposure to significant regulatory filings (e.g. NDA, BLA, MAA)* an advantage
Academic environment experience or related coursework will be considered towards experience requirements
Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements preferred
Bachelor’s degree in statistics, biostatistics, mathematics, computer science required
US military experience will be considered towards industry experience requirements
1600294

Biometric Sciences Statistical Programmer Resume Examples & Samples

Minimum of 4 years clinical / statistical programming experience related to pharmaceutical clinical development - Supporting significant regulatory filings (e.g. NDA, BLA, MAA)* preferred
Advanced post-graduate qualifications preferred, and would be considered in relation to minimum years’ programming experience
1505212

Principal Statistical Programmer Resume Examples & Samples

Influences other functions and represents as DOP technical expertise
Represent as internal team leader who decides best course of action
Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells
Provide programming support for the preparation of integrated reports, submissions and post-submission activities
Serve as an advisor to programmers assigned to the project to ensure high quality and timely deliverables
7 plus years Pharmaceutical/CRO industry experience, and or relevant experience, as a SAS programmer supporting clinical trials for
Regulatory submissions
Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate
Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC,
SDTM
In-depth understanding of regulatory, industry, and technology standards and requirements

Statistical Programmer Resume Examples & Samples

Demonstrate full proficiency in technical/programming skills
Master’s degree in computer science, mathematics or other scientific field +3 years’ experience or Bachelor’s degree in computer science, mathematics or other scientific field + 6 years’ experience programming and analyzing scientific data in pharmaceutical or biotechnology industry
Good communication skills in written and oral English.Biostatistics

Senior Statistical Programmer Resume Examples & Samples

Provide statistical programming support for a wide variety of projects ranging from extensive exploratory assessments to formally defined analyses
Responsible for production, maintenance, verification and documentation of analysis outputs and datasets
Work closely with members of the Biostatistics and Data Management group to meet project deliverables and timelines
Contribute to the development, documentation and maintenance of a programming code (macro) library
Maintain and develop standards and best practices for production, testing, and validation of programming code and analysis outputs
Exercise good judgment within broadly defined practices in selecting programming methods, techniques and evaluation criteria for obtaining high quality results
Maintain expertise in new developments related to Statistical Programming and provide guidance or recommendations in scientific programming techniques and use of software packages
Expertise in SAS programming, including SAS Base/Macro/ SQL/STAT/Graph/ODS
B.S. or M.S. in Statistics or related field. Minimum of 3-8 years of directly related experience, depending upon position level and degree
Understanding of basic statistical concepts and associated analyses methods
Ability to prioritize and drive to results with a high emphasis on quality
Ability to work independently on multiple concurrent projects in a fast-paced environment
Experience in exploratory analyses and in supporting publications and presentations at clinical and scientific conferences
Experience in program and output verification and familiarity with principles of software validation
Professional manner with ability to communicate and work effectively with other functions
Ability to integrate and apply feedback in a professional manner
Programming experience with R or another programming language
Experience developing/ maintaining best practice guidelines and SOPs related to programming code and data structures
Sound knowledge of common statistical methods
Experience with survival analysis methods
Experience with genomic analyses
Familiarity with regulatory requirements (e.g. GCP, FDA)

Senior Statistical Programmer Resume Examples & Samples

Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting
Independently develops analysis specification & programs
Has thorough knowledge of clinical trial study design and electronic data submission requirements
6 years of experience and a BS degree in Biostatistics, Computer Science or equivalent
2 years of experience and a MS degree in Biostatistics/Computer Science or equivalent
1 year of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent

Statistical Programmer Resume Examples & Samples

Assesses the quality and consistency of analysis data and performs cross-study analyses
Uses internal macros or writes SAS® macros to automate study deliverables
Works as a primary programmer for multiple Phase 1-4 studies
Assists in submissions of electronic data (e.g., SAS® data sets) to regulatory agencies
Identifies potential issues in study documentation and proposes solutions
Contributes to strategic initiatives
Assist with study and systems audits by GSI Compliance Group and external bodies, and respond to audit questions and findings
Promote and communicate awareness of programming and the role of the Biometrics department (internal/external; scientific/process)
Excellent verbal and written communication skills and interpersonal skills are required
Must be able to work independently on multiple concurrent projects
5 years of experience and a BS degree in Biostatistics/Computer Science or equivalent
1 year of experience and a MS degree in Biostatistics/Computer Science or equivalent
PhD degree in Biostatistics/Computer Sciences or equivalent

Statistical Programmer Resume Examples & Samples

Provides support for basic programming tasks and performs modifications to existing programs, under close supervision
Uses internal analysis macros to automate study deliverables
Adheres to all GSI Policies, SOPs and other controlled documents
Provides inputs to and participates in Programming and Biometrics meetings
Works as a secondary programmer for Phase 1-4 studies
May contribute to the continuous improvement of Programming Environment
Knowledge of computer programming, SAS, or other procedural languages

Senior Statistical Programmer Resume Examples & Samples

Bachelor’s degree in related field
Minimum 5+ years of hands-on industry experience
Clinical trial and drug development knowledge
Knowledge of industry standards, FDA and ICH guideline
Working experience with CDISC STDM/ADaM models and define document are preferred
Oncology experience preferred
Excellent analytical, critical thinking, writing, and communication skills
Strong SAS skills, including data manipulation in data step, SQL. Report writing with SAS ODS

Associate Principal, Statistical Programmer Resume Examples & Samples

The incumbent is responsible for the design and maintenance of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation
The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables
For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle
Key areas of focus include (1) the assurance of deliverable quality and process compliance, (2) effective deliverable development utilizing global and TA standards that optimize analysis and reporting and promote a strategic knowledge-base data model, (3) maintaining and managing a project plan including resource forecasting, (4) coordinating the activities of a global programming team that includes outsource provider staff, (5) membership on departmental strategic initiative project teams such as new statistical computing platform evaluation and development
Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise
Familiarity with statistical analysis methods and clinical data management concepts
Strong project management skills; A program leader; Determines appropriate programming methodology, assures programming consistency across protocols and projects, completes programming tasks, and directs the program development effort of other programmers; an experienced programming mentor; ability to engage key stakeholders
Experience in CDISC and ADaM standards
Ability to anticipate stakeholder and regulatory requirements

Senior Statistical Programmer Resume Examples & Samples

BS plus a minimum of 5 years or MS plus a minimum of 3 years SAS programming experience in a clinical trial environment
Knowledge and experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements
A project leader; completes programming tasks independently at a project level. Follows program-wide standards and suggests/develops additional standards; ability to engage key stakeholders
Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed; Understanding of statistical terminology and concepts; Designs and develops complex programming algorithms
Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders
Experience ensuring process compliance and deliverable quality
Ability to anticipate stakeholder requirements

Data Management & Statistical Programmer Resume Examples & Samples

Reviews study protocols and assist in the planning and implementation of the data management and statistical portions of clinical research projects
Participate in the development and review of data management documentation and statistical analysis plan
Spec, build and merge SAS datasets from various sources, including but not limited to raw, SDTM, ADaM, non-conforming data and then spec and build define.xml as required. (using Data Null or Proc Report, and Graphs using Proc Gchart or Proc Gplot, as indicated in the SAP and/or programming SOPs)
Use internal macros or write SAS macros to automate statistical table, graph, and listing production
Perform the IQ, OQ, and PQ validation of the SAS System
Develop SAS coding and table templates for preparing, processing and analyzing data
Write SAS programs to generate tables, listings, and figures and standardized analysis datasets
MS degree in Computer Science, Statistics, Life Sciences or relevant scientific subject with 3+ years of relevant experience or BS degree with 5 years of directly related experience
Experience with pharmaceutical industry standards and 3 years of experience in Phase I-III drug development programs
Biostatistical programming using SAS system
Extensive experience in the statistical analysis of biomedical data using SAS software or certified in areas of SAS programming: accessing data, creating data structures, managing data, and generating reports
Basic knowledge of reading and interpreting protocol and the ability to verify the CRF/eCRF/eSource and other data elements meet the analysis requirements
Understanding of 21-CFR Part 11 guidelines
Ensures compliance with established SOPS and current regulatory requirements

Statistical Programmer Resume Examples & Samples

Use efficient programming techniques to produce low-medium complexity derived datasets,
Knowledge of the programming and reporting process within the Statistical Programming
Show commitment to and perform consistently high quality work

Principal Statistical Programmer Resume Examples & Samples

The Statistical Programming Coordinator will
Demonstrated application of CRS concepts to achieve best practice and promote continuous improvement
Tenacity to work in an innovative environment
Ability to negotiate and influence in order to achieve results
Business/Operational skills that include customer focus, commitment to quality management and problem solving
Good business awareness/business development skills (including financial awareness)
Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial
Demonstrate commitment to refine quality processes
Effective time management in order to meet daily metrics or team objectives
Competent in written and oral English and Russian
Project leadership experience required
Proven record of leading a team and large scope of projects in a GRO, Technical, Clinical, Medical or Statistical environment

Statistical Programmer Resume Examples & Samples

Assist in the coordination of project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation
Use efficient programming techniques to produce derived datasets, tables, figures and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures and data listings
Proficiency in SAS
Knowledge of the programming and reporting process
Demonstrate ability to learn new systems and function in an evolving technical environment
Ability to successfully work together with a (“virtual”) team (including international teams as required) as well as independently
Clinical Trial industry experience

Senior Statistical Programmer Resume Examples & Samples

Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived
Develop wider knowledge of SAS and other relevant programming languages and processes
Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other
Strong leadership ability

Statistical Programmer Resume Examples & Samples

Assist in the coordination of project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g. setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation
Check own work in an ongoing way to ensure first-time quality
Proactively participate in quality improvement initiatives
Ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required
Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application. Demonstrate ability to learn new systems and function in an evolving technical environment
First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience
Language Skills
Minimum Work Experience

Senior Statistical Programmer Resume Examples & Samples

Specification development
Report programming
Liaise with Data Management Leads and Biostatisticians
Provide support to management for metrics, status reports, and meetings as required
Commitment to consistent high quality of work in a regulated industry
Experience with Windows PC and Microsoft Office applications
Understanding of Unix commands, file systems, and shell scripts
Understands quality and regulatory requirements with ability to identify risk potential from programming activities

Statistical Programmer Resume Examples & Samples

Data conversions and transfers
Knowledge of programming and reporting processes
Understanding of basic Unix commands and file systems

Senior Statistical Programmer Resume Examples & Samples

Input into and negotiate statistical programming timelines
Ensure that timelines are adhered to
Interact with Sponsors as the key contact with regard to statistical programming issues
Provide technical support and advice to the internal team
Ability to fill Statistical Programming Coordinator role on projects
5 plus years’ experience with leading clinical trials
Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
Educated to degree level in a relevant discipline and/or equivalent work experience

Statistical Programmer Resume Examples & Samples

Extensive knowledge and understanding of the programming and reporting process
Ability to successfully work together with a team well as independently including international teams as required
SAS Skills Essential
Experience in Clinical Studies – desirable

Statistical Programmer Resume Examples & Samples

A graduate or master degree in a relevant educational filed life science, computer, pharmacy, others
Proficiency in SAS and knowledge of programming and reporting process
Excellent experience with TLF, SAS coding, Macros, SQL, PROC reports, SDTM, ADAM (preferred)
Knowledge of WSOPs/ICH-GCP and System Life Cycle methodologies
Excellent communication (written & oral) skills and strong leadership ability
Strong organizational skills, flexible to change and team work
Ability to manage complex projects and business operational skills Study lead experience

Senior Statistical Programmer Resume Examples & Samples

Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents
Proactively participate in and/or lead process/quality improvement initiatives
Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change
Work effectively in a quality-focused environment
Competent in written and oral English
Strong relevant Clinical Trial Statistical Programmer industry experience

Senior Statistical Programmer Resume Examples & Samples

Input into and negotiate statistical programming timelines; ensure that timelines are adhered to
Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation
Work closely with the Quality Management Groups (QMG) to ensure compliance with
WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required
Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas
Provide relevant training and mentorship to staff and project teams

Principal Statistical Programmer Resume Examples & Samples

Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities
Provide oversight and guidance on multiple-trial programs, complex trials, and submission projects (including Integrated Summary of Safety or Efficacy)
Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g. setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation
Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to
Monitor project resourcing, project budgets, and identify changes in scope
Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed
Work closely with the Quality Management Groups (QMG) to ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required
Provide broad support, including advice on new technologies and industry technical standards (e.g. EDC, CDISC, Statistical principles, CFR Part 11, electronic submissions, applications and communications technologies, etc.) and their integration into Programming processes
Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings
Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department
Represent PAREXEL at sponsor marketing and technical meetings
Represent Statistical Programming on cross-functional technical initiatives

Statistical Programmer Resume Examples & Samples

At the direction of the programming lead apply standard tools developed for the study or project
Take direction from programming project lead to facilitate any additional requirements to support the programming deliverable
Adheres to procedures surrounding retention of data, records, and information for clinical studies

Senior Statistical Programmer Resume Examples & Samples

Maintain Pharmacometric SAS Network folder structure
Support the non-clinical CDISC/SEND data set initiatives
Bachelors degree +7 years experience or Masters degree +4 years experience
Prior experience in successful regulatory NDA/BLA submissions
Background in creating SDTM and ADaM data sets in SAS
Well experienced in SDTM and ADaM data set validation
Well experienced Generate and validate TLF
Experienced in in generation and validation of NONMEM data sets for Pop PK and PK/PD
Experienced in generation of high quality graph in SAS and/or R
Experienced in creation of exploratory PK and PK/PD data set from LIMS and clinical raw data sets
Prior experience in support of Clinical Pharmacology, modeling & simulation, and other pharmacometric activities
Proficient in Excel/ and Excel macro generation
Basic understanding of WinNonLin and NONMEM is desirable

Senior Statistical Programmer Resume Examples & Samples

Support creation and validation of esubmission requirements (i.e. annotated CRF, data export files, define documents)
Work in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reprots,. If applicable, develop and provide department training for applications and standard tools developed by the department functions group
Provide programming support for simple presentations and basic statistical ad-hoc requests. Assist in the more complex data presentations

Senior Statistical Programmer Resume Examples & Samples

Support the non-clinical CDISC/SEND data set initiative
2) Background in creating SDTM and ADaM data sets in SAS
3) Well experienced in SDTM and ADaM data set validation
4) Well experienced Generate and validate TLF
5 Experienced in in generation and validation of NONMEM data sets
7) Experienced in creation of exploratory PK and PK/PD data

Statistical Programmer Resume Examples & Samples

Develop and validate SAS® programs to produce high quality deliverables within set timelines in accordance with company and regulatory requirements. The deliverables include datasets, tables, listings and figures
Review and provide feedback on deliverables from other clinical groups including but not limited to: statistical analysis plans; table, listing, and figure shells; data management plans; data transfer plans; Safety Report Specification; electronic data entry screens; and case report forms
BS or equivalent relevant education and 3+ years or MS/PhD and 2+ years of software development and/or programming experience; years of experience may substitute for education
1+ years of programming experience using SAS®
Experience with oncology clinical studies
Experience implementing CDISC standards
Experience with additional programming languages and tools such as S-Plus, R, SPSS, Perl, VBA, MS Access, MS Excel, and SQL that interface with SAS
Positive attitude and an ability to creatively use programming skills across variety of tasks in the Clinical Programming area

Temporary Senior Statistical Programmer Resume Examples & Samples

Writing SAS programs from instructions provided by
Bachelor's degree in Biostatistics, Statistics, Computer Science, or a related field
5 years of SAS and relevant pharmaceutical industry experience, including CDISC SDTM and ADaM models

Senior Statistical Programmer Resume Examples & Samples

Strong technical programming experience
Experience managing a global programming team
5 plus years proficiency in SAS
SDTM and CDISC experience required
Strong mapping experience
Attention to detail, ability to be self-driven and solid organization skills

Senior Principal Statistical Programmer Resume Examples & Samples

Accountable for statistical programming activities for assigned projects. Delegate and coordinate statistical programming activities on a statistical deliverable ensuring timelines are met and best practices implemented
Create and manage project and study phase sub-directories ensuring consistency in processes and database structures across studies within the same project
Provide input into: CRF specifications to collect data specified in the protocol, database design, and query check specifications through review of the data management plan, data management report, and data quality surveillance plan
For clinical trials requiring complex data manipulation and analysis, provide input into medical and statistical supervision plans and statistical analysis plans
For clinical trials requiring complex data manipulation and analysis and for integrated summaries of efficacy and safety for regulatory submission dossiers, independently program (or write validation programs for) and document tables/listings/figures/analysis datasets and create the analysis dataset specifications
Interact with regulatory agencies regarding specifications for electronic submissions, and direct/develop statistical programming electronic submission deliverables
Create and validate clinical trial randomization programs if not performed by a vendor
Participate effectively on clinical trial teams and as an ad-hoc member on clinical development teams
Provide statistical programming support for Data Monitoring Committee charters and associated statistical programming deliverables
Plan, communicate and implement the surveillance of the statistical programming activities performed by a Contract Research Organization
Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency
Provide input into or lead standard statistical application development deliverables such as electronic submissions and programming macros including standard statistical data output software
Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation
Provide input into, or lead general standardization efforts (e.g., CRFs, query checks, standard statistical programs, data presentations)
Lead process improvement teams as required and effectively communicate process improvement developments
Provide solutions for complex programming issues presenting alternatives and identifying the best solution
Keep abreast of SAS enhancements
Communicate technical programming concepts in a clear, concise, focused and articulate manner
Mentor biostatisticians and statistical programmers with advanced SAS programming techniques
Mentor statistical programmers on team performance and relevant therapeutic areas
Participate in the hiring of additional departmental staff
Provide timeline and resource forecasts for statistical programming deliverables
Preferably at least 9 years’ experience in the Pharmaceutical/Biotechnology industry in clinical development
Experience as a team leader or line manager
Experience as a lead statistical programmer on several concurrent projects
Extensive knowledge of relevant regulatory guidelines applicable to clinical development
Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to clinical and methodological development
Good working knowledge of the relevant statistical and therapeutic areas
Strong interpersonal skills and proactivity to cultivate a network of productive relationships in an international matrix environment

Principal Statistical Programmer Resume Examples & Samples

Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budge.Monitor project resourcing, project budgets, and identify changes in scope
Be trained in sponsor WSOP’s and disseminate knowledge to project team members as appropriate
Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, SQL, and other programming language usage and processes within the GRO, biostatistics, and medical arenas
Provide broad support, including advice on new technologies and industry technical standards (e.g., EDC, CDISC, Statistical principles, CFR Part 11, electronic submissions, applications and communications technologies, etc.) and their integration into Programming processes
Provide consultancy to internal and external sponsors with regard to statistical programming tasks. In addition, maintain visibility to these sponsors to ensure expectations are being met and that requirements are accurately distributed to the appropriate stakeholders
Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department

Principal Statistical Programmer Resume Examples & Samples

Effectively designs and codes SAS programs for assigned clinical projects(s), consistently meeting objectives of the study
Provides guidance on the resolution of highly complex clinical trial reporting problems within budget and time line constraints, while assuring high quality standards
Performs quality control checks of advanced SAS code and output produced by other Statistical Programmers
Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)
May supervise other statistical programming staff
Experience with creating all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE
Experience with the CDISC SDTM and AdaM models and transforming raw data into these standards
Experience working with all types of safety data and coding dictionaries (MedDRA and WHODRL) commonly used by the pharmaceutical industry
Experience working in a team environment providing technical leadership and solving clinical trial reporting problems of moderate to high complexity within budget and customary time line constraints while assuring high quality standards
Skilled at performing quality control checks of SAS code and output produced by other Statistical Programmers
Knowledgeable regarding software validation and system development life cycle concepts

Statistical Programmer Resume Examples & Samples

Perform and plan: (i) the programming, testing, and documentation of programs for use in creating statistical tables, figures and listing, (ii) the programming of analysis dataset (derived datasets) and transfer files for internal and external clients. and (iii) the programming quality control checks for the source data and report the data issues periodically
Detect errors in detail, corrects them (e.g., reviews tables/listings, edit checks output and SAS programs to ensure quality of deliverable) and report it to appropriate personals (internal or external clients)
Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department
Fulfill project responsibilities at the level of technical team lead for single studies, under supervision
Understand timelines for and milestones affecting their work and alert supervisor to potential slippage
Provide training and mentoring to SP team members
Ability to estimate programming scope of work and assist in communicating project status
Good organizational, interpersonal, leadership and communication skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients

Statistical Programmer -PK Resume Examples & Samples

Perform and plan: (i) the programming, testing, and documentation of programs for use in creating statistical tables, figures and listing, (ii) the programming of analysis dataset (derived datasets) and transfer files for internal and external clients. and (iii) the programming quality control checks for the source data and report the data issues periodically
Detect errors in detail, corrects them (e.g., reviews tables/listings, edit checks output and SAS programs to ensure quality of deliverable) and report it to appropriate personals (internal or external clients)
Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department
Perform and plan the development, implementation and validation of new process technologies, macros and applications
Fulfill project responsibilities at the level of technical team lead for single studies, under supervision
Understand timelines for and milestones affecting their work and alert supervisor to potential slippage
Provide training and mentoring to SP team members
Knowledge of statistics, programming and/or clinical drug development process
In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Ability to implement programming specifications, as appropriate
Ability to estimate programming scope of work and assist in communicating project status
Working knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
Exhibits routine and occasionally complex problem solving skills
Recognizes when negotiating skills are needed and seeks assistance
Good organizational, interpersonal, leadership and communication skills
Ability to effectively handle multiple tasks and projects, under supervision
Excellent accuracy and attention to detail
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Masters degree in computer science or related field and 1 year relevant experience; Bachelor's degree in computer science or related field and 3 years relevant experience; or equivalent combination of education, training and experience
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Occasional travel

Senior Statistical Programmer Statistical Analyst Resume Examples & Samples

Program, plan and co-ordinate: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables and listing summaries, (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients and (iii) the programming of database quality control checks
Program the integration of databases from multiple studies or sources
Develop and plan programming documentation including plans and specifications, as appropriate
Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and the Statistical Programming department
Perform and plan the development, implementation and validation of new process technologies, macros and applications
Fulfill project responsibilities at the level of Lead for single studies, under supervision
Manage project budget and resource requirements
Provide training and guidance to lower level and new staff
Masters degree or educational equivalent in computer science or related field and 1 year relevant experience; Bachelor's degree or educational equivalent in computer science or related field and 2 years relevant experience; or equivalent combination of education, training and experience
Knowledge of statistical computing applications such as Base SAS, SAS/STAT and SAS Macro Language
Familiarity with SAS Drug Development (SDD) and Clinical Data Integration (CDI) would be preferred
Good organizational, interpersonal, leadership, communication skills and multi-tasking abilities

Senior Statistical Programmer Resume Examples & Samples

Perform, plan co-ordinate and implement the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files for internal and external clients and (iii) the programming quality control checks for the source data and report the data issues periodically
Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies
Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies
Statistical programming in SAS within the CRO/Pharmaceutical/Biotechnology/Healthcare industries
In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Advanced knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
Ability to delegate work to other members of the SP team
Exhibits routine and occasionally complex problem solving skills
Ability to lead teams and projects and capable of managing at a group level
Masters degree in computer science or related field and 3 years relevant experience; Bachelor's degree or educational equivalent in computer science or related field and 5 years relevant experience; or equivalent combination of education, training and experience

Senior Statistical Programmer Resume Examples & Samples

Analysis of pharmacy claims experience and utilization looking for trends and issues that might impact commercial pharmacy spend
Forecast of pharmacy utilization, spend, and rebate impacting overall pharmacy spend
Ad - hoc analysis of potential issues related to pharmacy and drug related spend
Analysis of medical and pharmacy spend for various markets to determine trends
Gather inputs and requirements from pharmacists, other analysts or other sources for the modeling process
Develop financial forecast modeling various scenarios
Presentation of reports, forecasts and models to various stakeholders
3+ years of SAS
5+ years MS Excel / Access experience
Experience in extracting data from a large data store and validating results
Experience creating Excel / Access spreadsheet models to evaluate the financial impact of various business strategies
Experience with healthcare claims data
Tableau experience preferred
Ability to communicate methodologies used and resulting estimates to technical and non-technical audiences
Highly motivated to seek data - driven answers
Ability to conceptually break - down overall strategy into individual components for analytic purposes

Statistical Programmer Resume Examples & Samples

Conducts data management
Assembles data from multiple sources, resolves data problems and performs general data management tasks, including data integrity checks, query reports, and case selections using data control, definition and manipulations with considerable supervision and/or mentoring
Demonstrates nominal ability to work with data from multiple platforms
Begins to understand the statistical analysis implications of case report forms design and database design
Develops, writes, documents and tests basic statistical programs given the parameters and/or someone's sample code
Reviews, receives and cross-checks code from a more senior individual
Demonstrates basic ability to interpret biostatistics, epidemiological or general research results with considerable supervision and/or mentoring
Effectively communicates both verbally and in writing to other team members
Reviews and revises data from outside communications
Demonstrates ability in data management and to draft basic statistical programs
Experience in the use of standard statistical packages necessary
Knowledge of SAS or S-PLUS/R is required. Knowledge of SQL, Oracle or other relational database preferred
Beginning understanding of basic medical terminology
Demonstrates basic ability to interpret biostatistics, epidemiological or general research results
Prior experience in a health care research environment is desirable
Good organization, communication and time management skills are essential
Effective communication skills: fluent in English, sound writing skills, and ability to clearly communicate information both orally and in writing

Senior / Principal Statistical Programmer Resume Examples & Samples

Serves as the Lead Statistical Programmer for programs of projects
Coordinates the activities of other programming staff, monitoring progress on project deliverables
Participates in sponsor meetings, kickoff meetings and bid defense meetings as the Statistical Programming representative

Senior Statistical Programmer Resume Examples & Samples

At least 4-6 years of experience working as a statistical programmer within the pharmaceutical industry
Extensive experience with SAS programming
Extensive experience with validation and documentation of programs
Experience with clinical database technologies, data models and advanced programming
Experience with collaboration across professional and regional borders
Regular experience with communication and presentations

Statistical Programmer Resume Examples & Samples

Ensure quality control (QC) on all process and technical activities related to derived dataset, table,
Ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and
Ability to successfully work together with a (“virtual”) team (including international teams as
Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to

Statistical Programmer Resume Examples & Samples

Contributes to Statistical Programming Analyst (SPA) team in preparing summarized information to clinical study team members
Assist statistical programming activities at study level or components of a clinical project as applicable in order to support the teams
Under guidance of a senior SPA, develops approaches to meet the study and project requirements
Develops and is aware of timelines and scope based on resourcing / priority constraints within the SPA team to ensure understanding of their implications on individual work assignments
Familiar with the types of risks associated with a study and the impact on the quality of deliverables to ensure results are valid
Assist in determining and developing approaches to technical solutions to ensure process improvement

Uspa-statistical Programmer Resume Examples & Samples

Develop statistical programming routines in SAS for varied research needs. These include (but are not limited to)
Implementing complex stratified sampling designs
Variance estimation and formal statistical tests
Weighting
Data cleaning and error / outlier detection
Data mining (classification, drivers analysis, forecasting, simulations)
Constructing and validating benchmarks
Automated reporting and graphical display systems
Perform analyses of survey data under the guidance of a statistician or principal researcher
Collaborate with other researchers to resolve analytic challenges and develop solutions
Maintain, augment, and run legacy SAS programs
Bachelor's degree in in Mathematics, Statistics, Analytics, Data Science, or a related field
Advanced programming skill in SAS, R, C-based languages, or SQL
Interest in solving complex programming and analytical problems
Experience with statistical techniques such as comparisons of group means and proportions, correlation, association, regression (OLS, logistic), quantiles, statistical graphics
Self-motivated individual who enjoys working in a team and thrives in a deadline-driven environment
Client-focused
U.S. Citizen (due to Federal contract requirements)
Experience with data mining techniques a plus

Statistical Programmer Resume Examples & Samples

Perform and plan: (i) the programming, testing, and documentation of programs for use in creating statistical tables, figures and listing, (ii) the programming of analysis dataset (derived datasets) and transfer files for internal and external clients, and (iii) the programming quality control checks for the source data and report the data issues periodically
Detect errors in detail, correct them (e.g., review tables/listings, edit checks output and SAS programs to ensure quality of deliverable) and report it to internal or external clients
Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to Global Services teams
Provide training and mentoring to AA-HEOR team members
Knowledge of statistics, programming or clinical trial research and drug development process
In-depth knowledge of at least one of the following: epidemiology, health economics, electronic medical records, claims data, or health informatics
Experience with clinical coding systems, including ICD-9, ICD-10, CPT, RxNorm, and LOINC
Master’s degree in statistics, informatics, or related field and 3-5 years’ experience with electronic medical records or claims data
Bachelor's degree in statistics, mathematics, informatics, computer science or related field and 6 years relevant experience; or equivalent combination of education, training and experience

Senior Statistical Programmer Resume Examples & Samples

Ability to fill Primary Statistical Programmer role on projects. The Primary Statistical Programmer will
Provide a broad range of leadership and influencing capabilities to achieve the business objectives and goals for both PAREXEL and sponsors
Provide oversight and guidance on multiple-trial programs, complex trials, and submission projects (including Integrated Summaries of Safety/Efficacy)
Ability to learn new systems and function in an evolving technical environment

Principal Statistical Programmer Resume Examples & Samples

Codes complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic submissions of data in CDlSC format with minimal instruction or input from supervisor
Responsible for maintaining excellent working knowledge of medical data, the design and phases of clinical trials, statistics, relevant regulatory requirements, and the pharmaceutical industry- Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)
May conduct briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMEA, et cetera), on assigned projects
B.S. in Biostatistics, Statistics or Computer Science
Masters Degree or PhD in Biostatistics, Statistics or Computer Science
Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
Displays highly advanced knowledge regarding software validation and system development life cycle concepts

Statistical Programmer Resume Examples & Samples

Create standard macros and applications to improve the efficiency of the department.·
Maintain and expand local and international regulatory knowledge within the clinical industry
Develop mapping specifications for data exports in accordance with applicable standards
Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations
Relevant Clinical Trial industry experience (preferable)

Statistical Programmer Resume Examples & Samples

Codes complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDlSC SDTM format
Responsible for maintaining excellent working knowledge of medical data, the design and phases of clinical trials, statistics, relevant regulatory requirements, and the pharmaceutical industry
Manages project timelines and schedules of specific phases of projects and contracts with internal personnel and outside customer representatives
May conduct briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMEA) on assigned projects
Performs tasks with minimal instruction from supervisor
Bachelor's Degree in Biostatistics, Mathematics, Statistics, Computer Science, Life Science M.S. (or equivalent degree) and 8+ years of relevant work experience, or B.S. (or equivalent degree) and 10+ years of relevant pharmaceutical industry work experience
Experience writing SAS programs from instructions provided by Biostatisticians and Statistical Programmers to create data sets, tables, figures, and listings reporting results of clinical trials for investigational medications
Experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH

Associate Statistical Programmer Resume Examples & Samples

Cleaning and merging multiple data sets
Create member level datasets from claims level data
Act as data consultant
1+ years of and SAS programming experience including data analysis
Experience with administrative claims data

Principal Statistical Programmer Resume Examples & Samples

Develop, validate, maintain and document statistical analysis for clinical trials outputs (TRF) on the basis of the Statistical Analysis Plan, and of other trial documents (Protocol, CRF, Data Management Plan) following standard operating procedures, working documents, and established Good Programming Practice
Ensure the quality of trial datasets (SDTM and ADaM), metadata, tables, figures, listings, and statistical output
Act as subject matter expert on CDISC standards within department

Statistical Programmer Resume Examples & Samples

Uses SAS software (BASE, STAT, GRAPH, MACRO) for the production of well formatted datasets, tables, listings, and figures, per programming specifications, Statistical Analysis Plan, and other study related documentation
Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs in compliance with Company and sponsor standards
Develops specifications for outputs of low to moderate complexity. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework
Completes project programming activities within timeframe allotted by Lead Statistical Programmer and/or management. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. Keeps project team members informed of programming progress and issues requiring their attention
Regularly attends and prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others
Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business

Statistical Programmer -home Resume Examples & Samples

Programming all aspects of a clinical trial, from files to tables and figures
Programming from scratch
Working as part of a team
Using SAS in a quality control/ production capacity
Providing leadership to colleagues – even from a junior position
A Bachelor's degree or MSc in mathematics, biostatistics, statistics or the equivalent
New graduates with no work experience are welcome to apply
Alternatively, you should have an equivalent combination of education, training and experience

Senior Statistical Programmer Resume Examples & Samples

Develop programming plan for statistical outputs (datasets, tables, listings, figures, etc.) supporting clinical study reports, regulatory submissions and publications including resource needs and timelines
Independently create SAS programs for statistical outputs
Independently perform quality control on statistical outputs created internally or by vendors
Mentor junior programmers
Program SAS macros to support statistical outputs within a project, within a development program, across projects and across development programs
Assist in the development and maintenance of the SAS programming environment
Manage the Pacira programming effort on a project
Provide support in managing statistical programming performed by vendors
Provide reports to Biostatistics management on the status of statistical programs and outputs
Manage programming to timeline, alerting Biostatistics management to potential issues and delays
Provide CDISC expertise and ensure adherence to SDTM and ADaM standards
Provide SAS ODS expertise
Bachelor’s degree in statistics, mathematics, information technology, computer science or related fields is required
At least 5 years of experience programming in SAS with at least 2 years in the pharmaceutical industry
Data step
Macros
Statistical procedures
Output delivery system
Experience programming statistical analyses
Strong working knowledge of CDISC standards including
Study Data Tabulation Model (SDTM)
Analysis Data Model (ADaM)
Clinical Data Acquisition Standards Harmonization (CDASH)
Knowledge of R programming is a plus

Senior Statistical Programmer Resume Examples & Samples

Develop, maintain and validate analysis datasets, tables, listings and figures
Develop. maintain and validate local and global macros
Perform exploratory analysis as needed on the project
Establish programming timelines for assigned projects
Oversee CRO programming activities for assigned projects
Represent Statistical Programming team in project team meetings
Review and provide input to the CRF, Statistical Analysis Plan and other study documents
Develop, maintain and update SDTM and ADAM specifications as needed
Support and mentor junior programmers working on the project
BA/BS in math, statistics, computer science, life science or equivalent, plus 7 years of experience (5 years’ experience with MS/MA)
Experience in Phase III oncology studies
Experience using CDISC standards (SDTM, ADAM)
Recent NDA regulatory submission experience
Thorough understanding and ability in Base SAS
Excellent knowledge of SAS/Stat and SAS/Graph
Ability to create and debug SAS macros as needed
Understands Statistics and is able to interpret study results
Knowledge of other languages and tools used for reporting is a plus

Statistical Programmer Resume Examples & Samples

Prepares summarized information for clinical study team members
Lead statistical programming activities at study level or part of clinical project
Determines and develops approaches to meet the project requirements
Has an familiarity with the types of risks associated with a study and the impact on the quality of deliverables. Implements the risk based quality control accordingly
Provides technical solutions to a wide range of problems. Independently determines and develops approach to solutions
Negotiate effectively with customers for reasonable timelines and scope
Adapts to changing circumstances, policies, work assignments, and/or team members

Senior Statistical Programmer Resume Examples & Samples

Provides consistency and quality assurance across various projects
Independently identifies issues in the existing or future macros from previous experience and knowledge
Collaborates with Biostatisticians or Clinical Data Managers in defining macro specifications
Able to defend the rationale of produced macros
Demonstrates strong project management skills including ability to anticipate time, resources and staffing required to successfully complete a project
Demonstrates significant contribution to the improvement of global macros
Able to provide support for Application Development, Clinical Programming, Biostatistics requests
Works collaboratively with Biostatisticians, Statistical Programmers, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines
Assists in the preparation of submissions of electronic data (e.g., SAS® data sets) to regulatory agencies
Experience in Statistical programing and Clinical programming strongly favorable
Knowledge of database programming, Linux Operating system, and CDISC, eCTD a plus

RWI Data Scientist / Statistical Programmer Resume Examples & Samples

Advising on analytics plan or study design across broad functional users, including medical and internal business / commercial
Executing study plan or protocols using SAS, SQL, R or other statistical programming languages, prepare data, create new variables, and perform statistical testing
Responsible for the statistical contribution to retrospective and prospective research protocols to support RWI objectives
Leads the development and maintenance of SAS programs for the creation of tables, figures, and listings for each project. Must be able to meet timelines with minimal supervision of progress
Creates or implements data definitions as part of pre-specified and/or post-hoc analyses
Provides expertise to perform Quality Control of SAS and R programs as part of the peer review process
Develops programming expertise in advanced statistical and simulation methodologies
Follows internal and external procedures, best practice guidelines, and regulations including Astellas SOPs, ISPOR Good Practices for Outcomes Research, ICH-GCP, and internal standards such as templates and documentation standards
Meets regularly with internal and external stakeholders to ensure mutual understanding of the protocol design, required output and timelines
Where applicable, ensures compliance with the Astellas Standard Data Tabulation Model based on CDISC
Medical affairs / Health economics
Regional commercial
Pharmacaovigilance
Clinical Development
Strategic functions -- including product, portfolio and marketing strategy
Drug discovery research
External: Astellas partners, Vendors
Deep experience analyzing administrative claims database and EMR databases (e.g., IBM-Truven, Optum, Humedica, IMS Pharmetrics +, Flatiron, etc.)
Knowledge of coding against common real-world data types (claims and EMR) and common data models
Experience in health analytics and/or post graduate quant / stats & coding experience
Master/PhD Degree in Statistics, Biostatistics, Epidemiology, Mathematics, or Computer Science and at least 1 years relevant programming experience OR Bachelors and 3 years relevant programming experience
Excellent SQL programming skill with experience on large databases (i.e. millions of records)
Excellent SAS and R programming skills; Excellent understanding of SAS analytic tools (SAS/BASE, SAS/STAT, and SAS/GRAPH)

Senior Statistical Programmer Resume Examples & Samples

Knowledge of medical records
Knowledge of randomized controlled clinical trials principles, methodology, and procedures
Knowledge of federal and state regulations and guidelines pertaining to the conduct of clinical trials on human subjects
Ability to develop and deliver both oral and written presentations
Ability to establish data processing guidelines
Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment
Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards
Skill in the use of computer statistical, technical, and database applications
Ability to work through a Contract Research Organization
Bachelor’s Degree in Statistics or related scientific field
5+ years of experience that is directly related to the duties and responsibilities specified
Candidate must be highly motivated, have excellent interpersonal and written communication skills, composed under stress and well organized
Ability to develop technical analyses for reports and manuscripts
Experienced at effective presentation or meeting with FDA or other competent authority
Should have medical device experience – especially cardiovascular
Ability to independently develop novel concepts and techniques in regarding statistical programming
Broad knowledge of statistical data collection, editing, validation, and analysis techniques
Knowledge of the infrastructure and operational characteristics of contract research organizations

Senior Statistical Programmer Resume Examples & Samples

At least 8 years work experience in a programming role preferably supporting clinical trials or in the pharmaceutical industry following standard operating procedures and working practices
Proven experience in supporting/leading programming support for multiple clinical trials and submission activities (or equivalent)
Proven experience in development of advanced MACROs (such as MACRO's to support analysis data set and TFL creation) with high programming efficiency; strong programming and problem-solving skills
Working experience in pooling analysis datasets across multiple clinical studies (or equivalent)
Proven experience in development of datasets and dataset specifications in line with sponsor standards and CDISC implementation guides for ADaM and SDTM

Statistical Programmer Resume Examples & Samples

20 years statistical programming experience
Must be completely familiar with running SAS software and have at least 20 years of experience
Familiar with running statistics for field research (agriculture)

Statistical Programmer Resume Examples & Samples

Bachelor's Degree in life science, statistics, mathematics, computer science, or related field is required; Master's Degree is preferred
Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs
Demonstrated skills in using additional software tools and applications (e.g. MS office, XML)
Demonstrated ability to work in a team environment with clinical team members
Ensure consistency and adherence to standards within the project
Create Data Definition Tables (DDT) and converting TFLs to the required format for eSubmission

Statistical Programmer Resume Examples & Samples

4 plus years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for regulatory submissions
Write SAS programs to generate SDTM and ADAM datasets
Write and debug SAS programs/macros in Linux environment
Support to the development, validation, maintenance and enhancement of global macros as well as training on the same
Provide input to the design of the Application or Macro requirements

Senior Statistical Programmer Resume Examples & Samples

Manipulate large observational and electronic healthcare databases utilizing knowledge of SAS programming tools and techniques to discover disease prevalence, incidence and risk factors, describe drug utilization patterns and disease progression, summarize disease outcomes, support market research, and answer clinical development questions
Work with team to gather and interpret user requirements from CORE epidemiologists and outcomes research scientists; retrieve the required data from electronic healthcare databases; and develop disease cohorts, analytical datasets, tables and figures and perform validation activities following departmental standard operating procedures
Evaluate the data integrity of internally licensed electronic healthcare databases and collaborate with project team members and stakeholders to create standardized macros across different electronic healthcare databases, including outcome and exposure definition and standard data summaries
Act as a key collaborator with CORE scientists to ensure project plans are executed efficiently with timely and high quality deliverables and that projects are in compliance with departmental SOPs and good programming practices
One (1) year of experience in statistical programming of healthcare databases
Applicant must have experience in SAS such as: SAS/MACRO, SAS/SQL, SAS/GRAPH
Thorough knowledge of programming techniques (SAS) including data steps and procedures, analytical ability, sound professional judgment and familiarity with outcomes research or epidemiology required
Applicant must have knowledge in UNIX operating system and Oracle SQL
Ability to manipulate large databases, including complex data preprocessing, filtering, and manipulation using SAS programming, including developing programming algorithms as needed to process standard and non-standard data in a variety of formats
Applicant must have experience with sample strategies for large databases and implementing various observational methods and leading SAS programming projects; possess understanding of observational research or statistical terminology and concepts; and have the ability to comprehend data analysis plans which describe observational research and statistical methodology to be programmed
Must be able to work 40 hours per week 9:00a.m. to 5:00 p.m
Must have proof of legal authority to work in the United States

Statistical Programmer / Analyst Resume Examples & Samples

Develop and document SAS programs used in the production of statistical outputs
MS or BS in Statistics, Computer Science or a related field
Statistical programming experience related to clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other regulatory filing experience, including ISS or ISE experience is of advantage
Thorough understanding of ICH Guidelines and relevant regulatory requirements
Knowledge of industry data standards (e.g. CDISC SDTM and ADaM)
Competent in the use of the statistical software package SAS (BASE, GRAPH, MACRO and STAT)
Knowledge of "R" is of advantage
Written and spoken fluency in English

Statistical Programmer Resume Examples & Samples

4+ years of comparable statistical programming work within the industry or 3+ years of internal statistical programming experience
Bachelor s degree or higher in a relevant subject
Experience with related computing capabilities
Utilize common office and computer equipment effectively
Attend meetings throughout the building
Exercise good verbal and written English language skills
Be physically present in the office
Proven ability to work creatively and analytically in a problem-solving environment Desire to work in an information systems environment

Senior Clinical Statistical Programmer Ards Resume Examples & Samples

Minimum 8 years SAS programming experience in the pharmaceutical, biotechnology, and/or contract research organization industries or minimum of 3 years demonstrated advanced technical knowledge and expertise in the design and development of SAS Applications as related to the Pharma industry
Minimum of a Bachelor's degree
Extensive knowledge of Base SAS, SAS/GRAPH, SAS/STAT, and ODS Extensive knowledge and proven experience in design and development of SAS Applications
Experience as a Lead Programmer managing the daily activities of the Programming team
Experience in managing external client interactions and relationship building
Experience working with heterogeneous data structures
Ability to work independently and adept at managing multiple competing tasks
Good understanding of clinical data and pharmaceutical development
Knowledge and experience using SDTM and ADaM,data structures
Knowledge of FDA and ICH guidance Knowledge of clinical trial conduct and the data and reporting requirements for clinical trials
Knowledge of SAS programming techniques needed to produce outputs in accordance with specifications

Senior Statistical Programmer Resume Examples & Samples

Review and provide feedback on Master Plan for assigned project
Review and provide feedback on QC Validation Plan
Review and provide input to project timelines, and ensure that project timelines are met for both internal and external clients
Attend Statistical Alignment meeting
Assume responsibility for project study budget, and perform monthly time projections for each project
Attend internal team meetings and relevant client team meetings as needed
Archive relevant documentation and deliverables
Review and provide comments on statistical analysis plan and data display documents
Manage programming effort for deliverables, including coordination of programming activity among team of assigned programmers, tracking programming effort, handling installation documentation, facilitating communication with the other team members
File code/output/documentation associated with client delivery to defined electronic folder structures on an ongoing basis, and perform final archival activity at study close
Ensure that project tasks are completed with acceptable quality for both internal and external clients
Assist lead biostatistician with development of programming specifications for analysis datasets and tables/listings/figures, as appropriate to the project
Review and provide comments on programming specifications for analysis datasets and tables/listings/figures
Review statistical analysis plan and data display documents as needed, to provide feedback on programming feasibility and efficiency
Develop and/or validate analysis datasets and tables/listings/figures
Perform function of unblinded statistical programmer for relevant studies, including management of unblinded programming, installation and validation activities; filing unblinded code/output/documentation; and maintaining security of restricted files
Perform independent code review and unit testing (as needed) and utilize source code management software
Develop QC test plans and complete documentation for SAS code installs in QC and Production environments as needed for Statistical Programming activities
Perform other duties that may be requested by management as assigned
Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research
Experience with SAS/STAT and SAS/GRAPH
Ability to perform multiple tasks efficiently and accurately with minimal supervision while meeting deadlines
Ability to develop and conduct training sessions

Associate Statistical Programmer Resume Examples & Samples

Utilize BI SOPs and guidelines, the Programmer Task List, and trial and project documentation to support the programming requirements of the Medical Quality Review Plan (MQRP), the Statistical Analyses Plan (SAP) and other supporting reports for moderate to complex trials of Phase I – IV or at the project/substance level. Gains specific knowledge about the clinical data collected for the trial/project. Attends meetings as necessary (e.g. Trial Preparation Meeting, Blinded Report Planning Meetings, Medical Sub team meetings). Communicates with the project programmer on a regular basis and with other project team members as needed. Works as a team with other programmers. Keep management abreast of critical process issues, resource shortages and changes in timelines. Keep tracking systems current
Produce non-standard edit check and monitoring programs to support the clinical trial team in the medical and quality review of the data during trial conduct
Transform specifications in the Trial/Project/Substance/ Statistical Analyses Plan (TSAP) into fully documented and tested programs supporting both safety and efficacy displays and Analyses Data Sets (ADS) required for the Clinical Trial Report. This includes: standard displays that require complex data building programming prior to the call of a standard macro; moderate to complex safety displays unable to use a standard macro that are well specified by the trial team; efficacy displays that require a moderate amount of applied statistics knowledge in order to produce well documented tested efficacy programs; and the creation of Analyses Data Sets (ADS) that may require the application of statistical methods. Assumes the ownership role for the safety tables, listing and figures and ensures the specifications and testing aspects are documented as per company policies. Reviews the TLFs across the displays for consistency before sending them to the statistician
Provide support for the electronic submission to regulatory agencies worldwide. This may include the preparation of safety and efficacy data files, application programs and documentation. Performs quality control activities to ensure the quality of the electronic submission
Provide fully documented and tested programs utilizing project or substance data bases in support of integrated reporting for regulatory agencies, Investigator Brochures (IB), etc. Reviews TLFs for consistency across displays prior to sending package to the statistician
Maintain technical competence in selected areas, by keeping abreast of new and emerging technologies in hardware and software development with the purpose of increasing the overall efficiency or effectiveness in the department
As a mentor to other programmers, ensures staff members adhere to the SOPs, guidelines and working instructions. Assist in the updating of department documents as requested by the manager. Informally reviews current processes and suggests changes for process improvements. Helps create or provide training materials in supported area
Aids in the development of a comprehensive Medical Quality Review Plan (MQRP) to ensure the integrity, accuracy and completeness of the data in preparation for clinical reporting
Transform specifications in the Statistical Analyses Plan (SAP) into fully documented, validated programs supporting both safety and efficacy displays and Analyses Data Sets (ADS) required for the Clinical Trial Report, Summary of Safety/Efficacy reports or other project level reporting (e.g. Investigator Brochures (IB), Monitoring Committees). This includes: complex safety displays unable to use a standard macro, efficacy displays that require a moderate amount of applied statistics knowledge, Analyses Data Sets (ADS) that require the application of statistical methods. Assumes the ownership of safety displays and completes the required documentation. Reviews TLFs for consistency across displays prior to sending package to the statistician
Receives broad operating instructions in performing a majority of duties from manager and keeps manager abreast of programming status and issues

100

Statistical Programmer Resume Examples & Samples

Assist in the production and QC of analysis plans, TLF mock-shell development, derived dataset specifications, programming specifications, and other process supporting documents
Provide input into monthly PERFORM forecasts and monitor the completion of forecasted units
Create standard macros and applications to improve the efficiency of the department
Experience working with SAS system used within the Clinical Trial process

101

Statistical Programmer Resume Examples & Samples

Provide input as required at all meetings, discussions and activities covering aspects of Statistical Reporting on trial level activities
As required, make certain that documents and specifications are consistent and comply with company standards for specifications of analysis datasets, listings, summaries, figures and tables for phase I – IV clinical trials. 3.Program, according to specifications, analysis datasets, listings, tables, and figures for phase I-IV clinical trials and/or apply standard statistical methods (as Reporting Statistician in Phase I) to standardized PK study designs. 4.Track clinical trial milestones for ONC Biometrics deliverables
Maintain records for all assigned deliverables including archiving of trial analysis and associated documentation
Comply with pre-defined project / study standards and specifications. Meet established KPIs. Timely and high quality completion of Biometrics deliverables according to established objectives
Working knowledge and experience with SAS pre-ferred,
Good communication and interpersonal skills,
Ability to work well in a team,

102

Senior Statistical Programmer Resume Examples & Samples

Bachelor degree in Computer Science or Master degree with affinity for programming
Strong experience with SAS
At least 5 years of relevant experience in clinical research as a Statistical Programmer
ICH-GCP knowledge

103

Statistical Programmer Resume Examples & Samples

Experience working with large data sets is a must
Extensive knowledge and experience in prescription data, emr data, managed care data (plan / payer data), medical claim data, patient longitudinal data, healthcare affiliation data, promotional data etc
Data process: including access and read in different data, data merge, integration and analysis, summary statistics
Must have extensive programming expertise in SQL, PLSQL and good understanding of Oracle database architecture and Performance tuning
Must have experience with statistical tools SAS and/or SPSS Modeler
Unix and Linux scripting a big plus
Experience working with Patient-level and/or medical claims-level data
Logical thinking and inference: demonstrated clear and logical thinking, able to prioritize, strong ability in hypothesis formulation and knows how to ask right questions and how to look for answers / solutions

104

Senior Statistical Programmer Resume Examples & Samples

Provide technical planning to include overseeing the set-up of key macros and SAS programs
Demonstrate excellent problem solving skills, a proactive approach and a willingness to make decisions on a regular basis
Ensure quality of personal work and the work of the team when acting as a Lead Programmer
Prioritize personal workload and that of teammates; perform work with minimal supervision
Advise Senior Statistical Programming Staff of changes in scope of projects to enable the timely development of change orders
Good experience with CDISC standards including Define.xml files
Display a positive attitude at all times, promoting and contributing to good team spirit in a professional environment
Represent Statistical Programming during client audits ensuring study documentation is maintained and filed according to Covance processes
Assist with interviewing and selection of potential candidates
Carry out all activities according to Covance SOPs working within the framework of the Quality management System and to Good Clinical Practice (GCP)
Provide ongoing training and mentoring within Statistical Programming to ensure thorough knowledge of the processes used and the ongoing technical development
Perform other duties as requested by management
5 - 8 years experience with proven SAS skills within a clinical trials environment
Knowledge in all aspects of clinical trials from initial study set-up to study completion
Full knowledge and understanding of the processes and procedures used within a Statistical Programming environment
Able to identify training and development needs, opportunities for optimizing staff utilization and employing the most efficient practices
Excellent organizational skills and the ability to delegate and prioritize work to meet tight deadlines while maintaining high standards
Self motivation and ability to work independently with minimum direction
Excellent time management skills and the ability to work to tight deadlines whilst maintaining the highest standards of work
Good interpersonal skills and the ability to communicate appropriately withal levels of staff and confidently with other disciplines and external clients
A co-operative and team orientated approach
Team leadership experience, as demonstrated by ability to organize and motivate project teams

105

Senior Statistical Programmer Resume Examples & Samples

Develop SAS programs for SDTM, ADaM, client-defined analysis datasets, Patient Profiles, Tables, Listings and Graphs in support of the Statistical Analysis Plan, posters, manuscripts, Integrated of Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
Act as a Lead Programmer for projects
Represent Statistical Programming at internal and client meetings
Act as a Statistical Programming consultant to clients and internal customers in related disciplines e.g. Clinical Data Management, Project Management and Medical Writing

106

Senior Principal Statistical Programmer Resume Examples & Samples

A minimum of 10 years’ experience in provision of programming support for clinical trial management and reporting, preferably with at least 2 years of statistical programming responsibility with a CRO
Strong project management skills and supervisory skills gained from at least 3 years leading large scale projects
Extensive experience and proven skills in the use of SAS within a clinical trials environment including all processes / practices used within a Statistical Programming environment

107

Senior Statistical Programmer Resume Examples & Samples

Clear and proactive communication with Study / Project teams to clarify requirements and specifications, update others on assignment status, and to convey data irregularities
Provide active support on planned initiatives that facilitate infrastructure and process enhancements within Biometrics
Provide support for ongoing regulatory and safety reporting
Train and mentor junior programmers
BS or equivalent relevant education and 5+ years or MS/PhD and 3+ years of software development and/or programming experience in the Biotech, Pharmaceutical, Medical Device, and Health Care industries; years of experience may substitute for education
Advanced SAS® skills
3+ years of experience in performing statistical programming using SAS® for creating & testing Analysis Datasets, Tables, Listings and Figures for Phase I-IV clinical studies
2+ years of experience in writing SAS® Macros

108

Senior Statistical Programmer Resume Examples & Samples

Experience in SAS programming, preferably in a clinical data environment
Exposure of relational database structure
Ability to support study requirements with challenging timelines under direct supervision by the programming lead

109

Statistical Programmer / Data Analyst Resume Examples & Samples

The desire and ability to do serious data munging and data wrangling is essential. At minimum, we expect demonstrated experience with SQL plus knowledge of another data preparation language (preferably R and/or Python). Must be able to use these tools to merge large datasets, locate and clean messy records, recode missing values, convert between data formats, and construct standardized datasets for wider use
Because we believe in reusable, self-service analytics, the candidate should be prepared to develop interactive online tools to acquire and deliver data from/to our clients. We use the JavaScript MEAN stack (Mongo, Express, Angular, Node) but will look for those with a demonstrated ability to put data to work online
We need the persistence, curiosity, and teamwork skills to collaborate with technical and non-technical peers and to tackle challenging questions head-on. Candidates should be capable of directing their own work and asking (and later answering) questions that lead to effective utilization of our data and the philanthropic behaviors it represents
The candidate should be passionate about data and algorithms and should have a nose for finding new and innovative ways to collect, analyze, and visualize data in easy to consume formats. Demands change rapidly, so those who understand the importance of reproducible research and the value of detailed documentation are greatly preferred
We don’t require a specific background, but we look for the types of skills gained with training in computer science, information science, or applied mathematics. Advanced degrees (or similar self-directed research experience) are a plus
Experience with, exposure to, or interest in learning machine learning and data mining concepts such as regression analysis, network / graph analysis, text mining, market basket analysis, decision trees, association rules, geographic analysis is important
Experience with version control tools like Git is strongly preferred
Our work involves using data to tell stories. Therefore, the ability or interest in creating data visualizations in Tableau, ggplot, or similar will be helpful

110

Statistical Programmer Resume Examples & Samples

A Bachelors’ or Masters’ degree in Statistics, Economics, Econometrics, and Computer Science or a related field
At least two years’ of relevant quantitative experience analyzing data
Strong PL/SQL or SAS skills and an understanding of ICD 9/10, HCPCS J code and NDC codes
Ideally experience of working with large volumes of complex claims data

111

Principal Statistical Programmer Resume Examples & Samples

Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget
Assessment of technology and processes, to facilitate best practices, increase quality, efficiency, and productivity
Consult with sponsors on technical/regulatory issues
Mentor and train other members of the department
Lead and supervise and/or create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request

112

Principal, Statistical Programmer Resume Examples & Samples

Adheres to and responsible for monitoring compliance with departmental procedures and practices, technical and industry standards and programming concepts and conventions during all aspects of work
Builds effective working relationships with cross functional groups within BioMetrics and across BioMarin to ensure that customer/stakeholder needs are met
Leads the technical aspects of cross functional system development efforts
Leads development and project management of technical deliverables planning and design work
Leads development of clinical study related deliverables as necessary
Collaborates in the development of business needs assessments and negotiates effectively to meet technical objectives
Effectively utilizes assigned resources and manages deliverables completion to meet project timelines
Monitors contractor activities and reviews contractor deliverables as necessary
Responsible for every aspect of technical project deliverables quality
Works with Quality Assurance and Computer Systems Validation to develop appropriately scoped validation plans and documentation and supporting documentation
Responsible for the development of applications, standard reporting tools and system utilities for the statistical programming group and BioMetrics department
Designs and develops technical training materials to support role out efforts
Responsible for writing applications development related SOPs appropriately scoped to the BioMetrics department business needs
8 Years of relevant experience
BS in Math, Statistics, Computer Science, Biostatistics, or related applicable field. MBA or MS preferred

113

Senior Statistical Programmer Resume Examples & Samples

Be responsible for statistical tasks on assigned clinical trials e.g. RAP
Maintain efficient interfaces with internal and external customers with support of ONC Biometrics management and the Program Programmer/Statistician
Make certain that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities
Program and deliver, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for phase I-IV clinical trials and for pooled analysis with high quality and within milestones
In consultation with the statistician, develop specifications for analysis datasets, pooled datasets, and listings
Maintain records for all assigned projects and archiving of trial / project analysis and associated documentation. 8. Provide input on process improvement initiatives and participate in non-clinical project activities with support from GH

114

Statistical Programmer Resume Examples & Samples

Comply with company, department and CDISC standards and processes, support the review programming specifications as part of the analysis plans
Ensure timely and quality development and validation of datasets and outputs (datasets, tables, figures and listings) for study-documents according to specifications (as assigned)
Extend knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend functional meetings and trainings
Basic SAS experience within a Statistical Programming environment to develop and validate deliverables
Basic experience in contributing to statistical analysis plans and/or constructing technical programming specifications
Basic understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, ICH)
Basic communications and negotiation skills, ability to work well with others globally
Ideally 1-3 years of work experience in a programming role preferably supporting clinical trials or at least initial work experience as intern (no work experience for MS Statistics/Computer Science graduates)

115

Statistical Programmer Resume Examples & Samples

6 months programming experience using SAS
Some understanding of the clinical trial process
A cooperative and team oriented approach

116

Principal Statistical Programmer Resume Examples & Samples

Ability to apply extensive technical expertise and has full knowledge of other related disciplines to provide consultancy and advice on programming and wider related issues to other departments and disciplines
Good interpersonal skills and the ability to communicate appropriately with all levels of staff throughout the organization and confidently with other disciplines and external clients
Ability to promote a good team working environment, providing the client with a high quality service while recognizing our business needs
Good interview skills to ensure successful recruitment of high caliber candidates

117

Statistical Programmer Resume Examples & Samples

Develop and review SAS specifications, programs and output for the creation of SDTM, ADaM and client-defined analysis datasets, tables, listings and graphs in support of Statistical Analysis Plans
Assume team member responsibilities, including representing Statistical Programming at internal project team meetings and with support from senior Statistical Programming staff at client meetings
Demonstrate good problem solving skills, a proactive approach and a willingness to make decisions, seeking advice from senior Statistical Programming staff to confirm decisions when necessary
With sufficient experience assume the role of a Lead Programmer for low complexity projects
Understand scope of project in order to advise Senior Statistical Programming staff of changes in scope of projects to enable the timely development of change orders
18 months to 5 years experience as Statistical Programmer for management and reporting of clinical trial data
Demonstrated skills in the use of SAS
Good time management skills and the ability to work to tight deadlines whilst maintaining the highest standards of work
Cooperative and team-oriented approach
Self motivation and ability to work independently

118

Statistical Programmer Resume Examples & Samples

Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality
Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS and other programming language usage and processes within the GRO, biostatistics, and medical arenas
Use efficient programming techniques to produce low-medium complexity derived datasets, tables, figures and data listings
Active knowledge of programming languages is a plus

119

Statistical Programmer Resume Examples & Samples

Effectively designs and codes SAS programs for assigned project(s), consistently meeting objectives of the project
5 years of experience w/SAS in the pharmaceutical industry
6+ years of experience w/SAS in the pharmaceutical industry
Proven record of effective and successful project management tasks and skills
Demonstrates advanced knowledge of electronic submissions and CDlSC
Communicates effectively in verbal presentations and written technical reports to both internal and external customers

120

Senior Statistical Programmer Statistical Programmer Resume Examples & Samples

Fulfill project responsibilities at the level of technical team lead for single complex studies or group of studies
Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines
Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables
Use and promote the use of established standards, SOP and best practices
Provide training and mentoring to SP team members and Statistical Programming department staff
Experience as technical team lead directly engaging clients and coordinating tasks within a programming team
Excellent accuracy and attention to detail
Ability to delegate work to other members of the SP team [SPM]
Recognizes when negotiating skills are needed and seeks assistance

121

Senior Statistical Programmer Resume Examples & Samples

Support programmer within a study team involved in the creation and QC of analysis datasets with direct supervision by the programming lead. Maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies
Support programmer within a study team involved in the creation and QC of tables, figures, and listings (TFLs) in support of analysis requirements utilizing Regeneron tools and methodologies
Follow all company SOP and guidelines in the creation of the programming deliverables

122

Senior Statistical Programmer Resume Examples & Samples

Extract data from internal systems and work closely with the modeling teams to prepare data for analysis
Assist with further processing of the data to aid modelers during the development process
Perform data analysis tasks at the direction of a modeler
Translate business requirements into programming code for use within internal systems and models
Develop reports to inform management on model performance, and/or tools to facilitate understanding of model results
Model/Analytics Implementation, Deploy, production support and Maintain model performance monitoring processes
Be a good team player and comfortable to work in a team environments setting for project deliverables
Develop and/or maintain a library of commonly used module/macros and programs for data extraction, transformations, loads etc
5+ years of development experience using SAS (Unix), SAS EG
5+ years of Microsoft SQL Server development experience
5+ years of Program Development experience in SAS grid environments
Solid understanding of the full software development lifecycle (SDLC)
Knowledge on Agile/scrum project development methodologies
Exposure to work with Oracle or DB2 system
Windows and Unix system knowledge and shell/scripts development experience
Microsoft Office Products
Knowledge of Healthcare domain, Payment Integrity, COB business
R Package
Exposure to Netezza, Teradata or Hadoop
Hadoop and Big data tools system knowledge and Dev experience

123

Associate Statistical Programmer Intern Resume Examples & Samples

Assist with development of statistical analysis plans, table shells, programming, derived analysis datasets and written analysis specifications
Produce/program tables, listings and figures
Under supervision, perform data review and statistical review of output
Assist with protocol development, sample size calculation, protocol and CRF review
Assist in advising data management staff on database design, validation checks and critical data
Assist project lead in fulfilling project responsibilities and meeting statistical project deliverables
Attend internal project team meetings and teleconferences as necessary and appropriate
Currently pursuing PhD or Master's degree or educational equivalent in biostatistics or related field; or equivalent combination of education, training and experience
For Statistical Programmer role, will also consider those currently pursuing Bachelor degree (rising senior on track) or educational equivalent in biostatistics or related field; or equivalent combination of education, training and experience
Excellent written and oral communication skills including grammatical/technical writing skills
Excellent attention and accuracy with details
Familiarity with basic statistical methods that apply to Phase I-IV clinical trials
Strong individual initiative
Strong organizing skills
Strong aptitude for SAS computing package skills
Ability to effectively manage multiple tasks and projects
Ability to establish and maintain effective working relationships with coworkers, managers and customers
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Occasional travel

124

Statistical Programmer Resume Examples & Samples

Ensure understanding and compliance with defined programming specifications. Is responsible for the development of study-level programming specifications as required
Maintain QC compliance and tracking records for the assigned trial/project support
Ensures quality deliverables and compliance with validation process for audit readiness. Provides support to audit preparation as required
Under minimal guidance participates in establishing working relationship on individual studies with CROs according to agreed contract and internal business guidance
Under minimal guidance contributes to process improvement, standardization and other non-clinical initiatives
Quality and timeliness of programmer contributions as assessed by the Clinical Trial Team, the project team and the Group Leader
Effectiveness of communication and team behavior as assessed by the other CTS team members and clinical trial team
Contributions to initiatives related to process improvement, standardization and working with CROs

125

Senior SAS Statistical Programmer Resume Examples & Samples

Analyze complex healthcare claims data with SAS in several different environments (e.g., SAS Grid, IBM Mainframe)
Work is accord with our standards for quality management
Collaborate with other programmers in a team environment
Assist in the preparation of data for client reports, journal manuscripts, and abstracts/posters
Participate in the development of the center’s initiatives
BS/BA degree in computer science, statistics, or health policy and a minimum of 10 years SAS programming experience; Advanced degree in computer science, statistics, or health policy and a minimum of 6 years SAS programming is desirable
Demonstrated communication skills, both written and verbal
To qualify, applicants must be legally authorized to work in the United States and not require sponsorship now or in the future
Experience with Linux/Unix and IBM Mainframe is highly desirable
Research experience in contract work with the Center for Medicare & Medicaid Services or in a health-related field is highly desirable

126

Senior Statistical Programmer Resume Examples & Samples

Demonstrated ability to work in global teams, as well as, manage projects independently
Capable of performing all the roles encompassed in the preceding levels within the job family as required by the organization
Must conduct activities in compliance with all relevant regulations such as ICH, GCP, and CFR, as well as all Shire policies and procedures. Shire policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives

127

Senior Statistical Programmer Analyst Resume Examples & Samples

Considers strategies in programming and analysis in order to allow consistency or continuity of subsequent tasks (e.g., multiple studies in an ISE or ISS)
Determines technical objectives and direction for project(s) and develops timelines for SPA component of the study to ensure deadlines are met
Prioritizes and delegates tasks based on the importance of the deliverable and awareness of overall timelines in order to efficiently produce high quality deliverables
Proactively addresses project uncertainties to the appropriate person (project team member, Lead SPA, or management) in order to minimize risks
Able to access and clarify requirements, provide statistical programming solutions to ensure their efficient implementations
Ensuring quality of deliverables
Responsible for accuracy and reliability of results, builds and monitors quality in every aspect of job activities to ensure quality control
Provides technical solutions to a wider range of problems with higher level of complexity in order to support statistical programming & analysis

128

Senior Statistical Programmer Resume Examples & Samples

BS plus 5-9 years or MS plus 3-7 years SAS programming experience in a clinical trial environment
Preferred Experience and Skills
Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables
Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor
Experience developing and managing a project plan using Microsoft Project or similar package
Active in professional societies

129

Statistical Programmer Resume Examples & Samples

Knowledge of one or more programming languages
Knowledge of statistics and/or clinical drug development process
Knowledge of statistical computing applications such as Base SAS, SAS/STAT, and SAS Macro Language
Good organizational, interpersonal, communication skills and multi-tasking abilities
Capable of problem solving
Able to debug and resolve code issues independently
Excellent attention to detail and quality-driven
1-3 years of statistical programming in a clinical trial environment (i.e. pharmaceutical, biotechnology, and/or contract research organization industries)

130

Senior Statistical Programmer Resume Examples & Samples

Ability to accept direction of lead team members
3-5 years of statistical programming in a clinical trial environment (i.e. pharmaceutical, biotechnology, and/or contract research organization industries)
Experience programming and reporting with Base SAS, SAS/Macro, SAS/STAT, SAS Language, SAS/ODS and SAS/Graph

131

Principal Statistical Programmer Analyst Resume Examples & Samples

Support E4A asset leads in corresponding TA to design, execute, and publish observational research with in-house claims/survey/EMR data
Participate in E4A asset strategic planning and lead the execution of RWD studies with internal resource on behalf of E4A asset lead
Develop and/or oversee research protocol and statistical analysis plan. Design and execute appropriate methodology (e.g., propensity score matching, regression analysis,…etc) for RWD studies
Mentor junior staffs/analysts to conduct the analyses, to review the results, and to

132

Statistical Programmer Resume Examples & Samples

Understanding, planning, and preparation of Modeling and Simulation science needs
Programming PKS and NONMEM datasets, statistical summary tables, listings and graphical reports
Detection and tracking of data issues
Assist with and/or generate and maintain regulatory documentation (i.e., metadata required for CDISC ADaM as well as non-CDISC data submission, assistance with data reviewer guides)
Work in a team setting with offsite contractor programmers

133

Statistical Programmer Resume Examples & Samples

Develop and review SAS programs and output for the management and reporting of clinical trial data including ADaM and client-defined analysis datasets, tables, listings and graphs
Develop programs for data transfers and assist in their review to ensure the data transfer has been produced to specification
Review draft and final production runs for project to ensure quality and consistency
Develop good problem solving skills and a willingness to learn and seek advice from senior Statistical Programming staff
Acquire knowledge of other aspects of the work of a Statistical Programmer Analyst under the supervision of the senior Statistical Programming staff

134

Senior Statistical Programmer Resume Examples & Samples

Translate business requirements into SAS code for use within internal systems and models
Model/Analytics Implementation, Deploy and Maintain model performance monitoring processes. Become one of the Predictive Analytics teams experts on internal servers and databases
Develop and/or maintain a library of commonly used macros and programs for data extraction, transformations, etc
5+ years of development experience with SAS (Unix), SAS EG & SAS Tools
5+ years of experience with SQL, Oracle or DB2 or MS SQL Server or Hadoop
5+ years of software development experience on SAS grid environments
Knowledge and process experiences using SDLC for Advanced Analytics implementations for FWAE predictive analytics models, anomalies detection analytics
Knowledge of Optum Insight Payment Integrity, Medical and Behavior Health claims payments processing including CPT and Diagnosis Code for FWAE (Fraud, Waste ,Abuse, Error) detections
Claim Data Analytics Integration with SAS or any ETL development experience
Knowledge of ICD-10 coding of Medical claims
Microsoft Office Products experiences
Development experience in Data sourcing from Netezza, Teradata or Hadoop
Project Management experiences on analytic deployment
XML domain knowledge

135

Lead SAS / Statistical Programmer Resume Examples & Samples

Lead and direct a team of up to 5 dedicated SAS programmers/analysts
Work with applicable stakeholders to develop understanding of the business need to be addressed by the analysis
Identify and utilize applicable data sources and platforms (e.g., claims, membership, transactions, health assessments)
Extracting data, cleaning, and merging multiple data sets using applicable UHG data sources
Perform data cleaning/QA/verification, as needed (e.g., self-review, peer review)
Analyze/interpret the results of the analysis and develop appropriate conclusions and recommendations
Compile and disseminate results of data analyses (e.g., data displays, PowerPoint decks, summaries, peer-reviewed publications, research presentations)
Communicate technical information effectively to both technical and non-technical audiences (e.g., understand audience needs, translate data into readily-understood terms)
Ensure proper documentation of data analysis methods and approaches, adhering to applicable documentation guidelines (e.g., DMS artifacts)
Provide technical data support for research studies (e.g., identify and escalate data issues to applicable IT resources)
Perform applicable technical support activities, as needed (e.g., manage storage space, archive files, and troubleshoot hardware/software issues)
Apply knowledge of coding methods (e.g., NDC, CMS, clinical coding, ICD-9, ICD-10, CPT, DRGs)
Apply knowledge of group and individual insurance processes (co-payments, sharing, co-insurance
Act as data consultant and subject matter expert in support of client requests
BS or BA Degree
2+ years of Healthcare or Pharmacy Industry experience
4+ years of SAS experience
Intermediate to Advanced Excel experience
Strong Pharmacy claims data and analytic experience
Able to conduct the analysis and work with other analysts summarize the results and communicate effectively
Strong Presentation skills
Ability to explain technical concepts to non-technical audiences
Ability to organize work effectively and efficiently
Experience managing a staff or leading a team
BS or BA in Health Economics, Statistics, Healthcare services research required, Finance, Business, or related
PBM experience
Perform applicable statistical analyses as necessary to provide appropriate information (e.g., correlation, regression, chi-square, t-tests, ANOVA, multivariate analysis)

136

Statistical Programmer Resume Examples & Samples

Review and provide feedback to the trial or project statistician regarding the scientific portion of the statistical analyses plan and the shell mockups for completeness, correctness and adherence to cited department guidelines and SOPs. Co-author the Analysis Data Set (ADS) specification with the statistician. Organize and chair the SAP Technical Challenge meeting. Ensure programming issues are resolved and specifications are kept updated in the SAP. Communicates with the CRO programmer when part of the programming or double programming is outsourced
Establish project and substance databases following the rules of good data base structure and data base integrity. The structure of the data base must support the execution of the standard safety macros
Help maintain libraries of fully documented and validated programs, macros and procedures which can be reused by other programmers to aid in the efficiency for the department
Utilizes the BI guidelines, protocols, annotated case report forms, Oracle*Clinical study definitions, trial and project data handling rules and standards, and Statistical Analyses Plans in preparation for the statistical programming of safety and efficacy CTR display programs and Analyses Data Sets (ADS) for complex trials, drug projects and substances. Gains specific knowledge about the users’ environment, data and software and hardware needs. Attends meetings as necessary (e.g. Trial Preparation Meeting, Blinded Report Planning Meetings, Medical Sub Team meeting). Communicates with the project programmer on a regular basis and with other project team members as needed. Keep management abreast of critical process issues, resource shortages and changes in timelines. Keep tracking systems current
Review and provide feedback to the trial or project statistician regarding the scientific portion of the statistical analyses plan and the shell mockups for completeness, correctness and adherence to cited department guidelines and SOPs. Co-author the Analysis Data Set (ADS) specification with the statistician. Organize and chair the SAP Technical Challenge meeting. Ensure programming issues are resolved and specifications are kept updated in the SAP
Ensures data base standards are adhered to and referential integrity is followed
Oversees and delegates programming development to other team members. Communicates with the CRO programmer when part of the trial programming or double programming is outsourced

137

Principal Statistical Programmer Resume Examples & Samples

Act as the Lead Programmer overseeing technical planning for increasingly complex projects including global and multiple study projects, Integrated of Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) and electronic submissions
Act as the Biometrics Project Manager for assigned projects
Review and interpret Statistical Analysis Plans and provide comments for assigned projects
Provide ongoing supervision, advice and consultation to Lead Programmers and programming team to ensure timely and efficient completion of projects
Provide feedback to management on the development potential of staff to assist in staff development
Perform interviews for selection of potential candidates
Ensure that study documentation is maintained to the standard required according to processes and acceptable for audit
Provide input into assessments of resource requirements on regular basis. Provide feedback to management if any action is needed to increase utilization, improve efficiency or amend the resource levels required on a project
Encourage and participate in the ongoing review of the processes used by the statistical Programming group to ensure processes are continually improved
Carry out all activities according to Covance SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP). Ensure adherence to programming guidelines
Perform other duties as assigned by senior Statistical Programming staff

138

Principal Statistical Programmer Resume Examples & Samples

Proven experience in leading programmer support for multiple clinical trials and submission activities (or equivalent)
Working knowledge of database design/structures and basic statistics. Working experience in pooling analysis datasets across multiple clinical studies (or equivalent)
Good understanding of global clinical trial / project practices, procedures, methodologies
At least 8 years work experience in a programming role preferably supporting clinical trials/ or in the pharmaceutical industry (5 years for MS Statistics / Computer Science graduates)

139

Senior Statistical Programmer Resume Examples & Samples

Effective interpersonal skills and ability to negotiate and collaborate effectively
Effective English written, oral, and presentation skills
Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise
Ability to quickly and effectively learn new program techniques and data structures; capacity to seamlessly assimilate to new projects
Basic understanding of statistics, clinical and data management concepts as applied to drug/vaccine development within the pharmaceutical industry
Ability to comprehend analysis plans which may describe health economics research and statistical programming methodology to be programmed; an understanding of statistical terminology and concepts
Efficiently manipulates large databases including complex data preprocessing, filtering and manipulation; experience with sample strategies for large databases
Unix operating system experience; Oracle SQL experience; systems and database experience
Thrives working in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements
An interest to advance career by investing in development activities and taking on tasks with increasing levels of challenge and responsibility
Knowledge in CDISC SDTM and ADaM standards
Team oriented with demonstrated history of teamwork and collaboration; enjoying diversity, respect and integrity
Experience in supporting analysis and reporting deliverables for Predictive Economic Modeling
Familiarity with the fields of Outcomes Research and Epidemiology
Experience working with coding systems such ICD-9, READ/OXMIS, and ICD-10

140

Senior Statistical Programmer Resume Examples & Samples

Co-ordinate activities of all programmers either internally or externally (FSP, CRO) assigned to the study/studies. Make statistical programming recommendations at study level
Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope), e.g. as member of the Clinical Trial Team
Review eCRF, discuss data structures and review activities as member of the Data Review Team
Comply with company, department and CDISC standards and processes, review and develop programming specifications as part of the analysis plans
Provide input into statistical programming solutions and/or ensure their efficient implementation
Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications
If assigned to cross-project aligned group (e.g. Standards), be responsible for an end-to-end development of a macro or utility function, or at least one local project under supervision
Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results
Maintain up-to-date knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend functional meetings and trainings

141

Biometric Sciences Statistical Programmer Resume Examples & Samples

Apply knowledge of the drug development process, clinical trial methodology, and common statistical terminology to support analysis and reporting of clinical data
Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with assignment objectives and requirements
Perform programming in accordance with project standards, programming conventions and programming specifications
Maintain simple to moderately complex programs and utilities in accordance with predefined specifications and BMS standards
Develop and debug simple to moderately complex programs for the analysis & reporting of clinical data
0-3 years programming experience in industry, US Military or Academic environment. (Academic experience or related coursework will be considered towards experience requirements.)
Rudimentary knowledge of SAS (Statistical Analysis Software): i.e. Base SAS product, with general computing knowledge related to clinical development activities preferred
Some clinical / statistical programming experience related to pharmaceutical clinical development
Knowledge of the drug development process, clinical trial methodology and statistics preferred
Experience with the Unix operating system
Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required

142

Associate Lead Statistical Programmer Resume Examples & Samples

BSc. or equivalent qualifications
At least 5-7 years of experience working as a statistical programmer within the pharmaceutical industry
Experience with the statistical software package SAS
Extensive experience with reporting clinical trials, including statistical data handling, analysis and reporting
In-depth knowledge of drug development
In-depth knowledge of computer systems and IT
Good knowledge of GxP and guidelines within drug development

143

Prin Statistical Programmer Resume Examples & Samples

Lead and execute programming deliverables on multiple projects in parallel and ensure that competing priorities are managed appropriately
Lead and manage the assigned programming team’s deliverables at the study and program level to ensure project objectives are met within budget, to agreed timelines and to the highest standard of quality
Proactively plan for and implement effective resource planning, task allocation and tracking of workload in accordance with agreed metrics (e.g. KPIs) and quality standards
Serve in a client-facing capacity that demonstrates an ability to anticipate client needs and implement innovative solutions, as appropriate
Develop and foster client relationships through effective project management and communication
Apply exceptional technical capabilities and knowledge of industry trends to develop broad-use technical solutions for the benefit of study teams across the department
Develop, implement and maintain documentation to technically train staff in the appropriate technical solution
Actively participate in the review and approval of programming procedures and techniques

144

Senior Statistical Programmer Resume Examples & Samples

Recognize, exemplify and adhere to ICON's values which centersaround our commitment to People, Clients and Performance
As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
As an experienced staff member, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
Travel (approximately 0%) domestic and/or international
Works effectively on multiple projects delivering quality output in a timely fashion
Programs analysis datasets, listings and tables without supervision and offers advice to others within team
Able to work on complex programming assignments and share knowledge appropriately
Plans ahead, performs early review of all assigned project work - escalates any issues
Is responsible to ensure that all output with a project is accurate and has consistent appearance
Creates and maintains study documentation and files according to departmental policy
Maintains professional currency through literature reviews and membership to professional bodies
Identifies training needs within SAS team and puts in place specific initiatives to helps Indian staff to develop their skills
Attends project team meetings, as required, and looks for opportunities to improve programming process across projects
Uses technical skills to bring forward better methodologies and approaches to coding. Leads process and programming improvement through broader knowledge
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Educational Requirements

145

Statistical Programmer Resume Examples & Samples

Perform all SAS programming required for clinical trial analysis and reporting
Generate tables, listings, and graphs as specified in the Statistical Analysis Plan, or on an ad hoc basis
Provide statistical programming expertise for project teams
Participate in developing the Statistical Analysis Plan
Design & develop SAS macros and other utilities to expedite SAS programming activities
Participate in statistical program quality control activities
Collaborate with other departments, such as Data Management, Clinical Operations and Project Management, to ensure a successful execution of clinical trials
Participate in review process of study documents such as the CRFs, edit specifications written by Data Management, and Statistical Analysis Plans
Program data edit checks, as necessary, to facilitate Data Management's data cleaning activities
Develop and maintain the infrastructure for project files of SAS datasets and SAS programs
Ensure all programming activities and processes performed are conducted according to standard operating procedures
Strong analytical skills, with the ability to process scientific and medical data
Strong SAS programming skills required, with proficiency in SAS/Base, and SAS Macros
One year of experience programming with clinical trial data
Understanding of standards specific to clinical trials, such as CDISC and MedDRA
Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues
Good organizational and time management skills, with the ability to multi-task
At least a basic understanding of SAS/Graph
3+ of experience programming with clinical trial data

146

Senior Statistical Programmer Resume Examples & Samples

Locally coordinate and take responsibility for trial level programming activities (analysis datasets, pooled datasets, listings, tables and figures) of individual Phase I-IV clinical trials to support program programmers and statistician in project level activities
Provide input on process improvement initiatives and participate in non-clinical project activities with support from GH
Intermediate knowledge and experience with SAS preferred
Demonstrated ability to take responsibility for deliverables

147

Associate Statistical Programmer Resume Examples & Samples

Utilizes BI SOPs and guidelines, trial protocols, annotated case report forms, Oracle * Clinical study definitions, trial and project data handling rules and standards and Statistical Analyses Plans in preparation for the programming of the Data Quality Review Plan (DQRP) and primary focus on the safety tables, listings and graphs (TLG) required for the Clinical Trial Report (CTR). Gains specific knowledge about the clinical data collected for the trial
Produce well documented validated standard and non-standard edit check and monitoring programs to support the clinical trial team to ensure the integrity, accuracy and completeness of the data in preparation for clinical reporting
Review the programming specifications and table mockups in the Trial Statistical Analyses Plan (TSAP) for completeness, correctness and adherence to sited department guidelines and SOPs. Ensure all programming issues are resolved and updated in the TSAP. Ensure additional specifications once programming commences are properly documented
Transform specifications in the Trial Statistical Analyses Plan (TSAP) into fully documented, validated programs required for the Clinical Trial Report. This includes: a. standard displays that require moderate to complex data building programming prior to the call of a standard macro. b. safety displays of moderate complexity unable to use a standard macro that are well specified by the trial team
Provide support for the electronic submission to regulatory agencies worldwide. This may include the preparation of safety data files and electronic documentation. Perform validation activities to ensure the quality of the submission
Help maintain libraries of fully documented and validated programs, macros and procedures which can be reused by other programmers to aid in the efficacy for the department
Maintain technical competence in selected areas (such as the SAS programming language, PCs and Unix), by keeping abreast of new and emerging developments with the purpose of increasing productivity or effectiveness in the department

148

Intern, Statistical Programmer Resume Examples & Samples

Support initiatives including programming in the area of clinical data management and statistical analysis
Assist in submission data preparation, especially the attempt to automate the process of SDTM mapping, eCRF bookmarking, spec sheet entry, tabulation/analysis data creation
Implement data validation checks and standardize the programming
Generate tables, listings, and figures
Test and validate SAS programs
The successful candidate will have preferably completed a minimum of their sophomore year and be currently enrolled in an accredited college or university in a Statistics, Computer Science, Math degree program, or a related field of study. A minimum 3.0 GPA is strongly preferred, however, a combination of experience and/or education will be taken into consideration
Must possess strong programming and software developing skills
Must be a quick learner
Must be able to work efficiently with Python or VBA (or .NET). Basic knowledge of SAS is also expected
Must be comfortable with Linux/Unix as well as Windows
Must possess knowledge of basic statistical concepts
Knowledge of CDISC standards, such as SDTM, ADaM, and Define.xml is a plus

149

Principal Statistical Programmer Resume Examples & Samples

4+ year’s experience with statistical programming aspects required for regulatory submission related to therapeutic drug development
Familiar with Python, R, C++
Familiar with source code management concepts and application

150

Statistical Programmer Resume Examples & Samples

Acts as the Lead Statistical Programmer for projects of various size and complexity
Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs and SAS database design, providing feedback to the appropriate project team members to reduce inefficiencies in programming activities where appropri
Degree educated or equivalent in Mathematics, Statistics, Computer Science, or related field
Strong organisational, presentation and communication skills

151

SAS / Statistical Programmer Resume Examples & Samples

Create and maintain programs and utilities in accordance with predefined specifications and Adaptimmune standards
Troubleshoot and debug code in non-system analysis & reporting programs to support implementation of technical solutions for integrating and analyzing clinical data
Apply knowledge of the drug development process, clinical trial methodology, and common statistical terminology to support validation of clinical data
Deliver clinical data analysis to development teams (including in stream reviews) and assess reporting requirements using common practices
Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan, eCRF) to ensure alignment with assignment objectives and requirements
Carry out programming in accordance with project standards, programming conventions, programming specifications and file transfers
Assess processes and procedures involved to bring together disparate inpatient datasets (including across studies) into one cohesive dataset that is ready for use by analysts
Create analysis datasets, generate and QC summary tables, logs, data listings, and graphs for study and validation of the data using SAS standard coding techniques
Bachelor’s or Master’s degree in statistics, biostatistics, mathematics, and/or computer science required
3-5 years statistical programming experience in pharmaceutical/biotech or CRO, or Academic environment
Proficiency in SAS (Statistical Analysis Software): i.e. Base, Stat, Graph components, with general computing knowledge related to clinical development activities preferred
Programming in the CDISC environment
Exposure to significant regulatory filings (e.g. NDA, BLA, MAA)
Academic environment experience or related coursework
Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements including CDISC standards is preferred
Works well under pressure and on multidisciplinary, virtual teams
Works independently - self-directed, high energy and strong work ethic
Ability to adapt effectively to changing priorities

152

Principal Statistical Programmer Resume Examples & Samples

Act as independent lead on the Oncology Biometrics reporting activities for a global project following general principles of project management guidelines including resource planning with minimal guidance and support from group head
Be responsible for all statistical tasks on the assigned clinical trials, and perform these tasks with a high level of independence e.g.: RAP including exploratory analyses and additional analyses to support publications, plus statistical consultation during the running phase
Maintain efficient interfaces with internal and external customers with support of ONC Biometrics management and the Program Programmer/Statistician. 4.Ensure that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I-IV clinical trials, submission activities and project level specifications e.g. pooled analysis and monitor adherence in execution
Oversee programming style, quality of Oncology Biometrics contributions and ensure compliance with time lines quality within milestones
Maintain records for all assigned projects and archiving of trial / project analysis and associated documentation
Train staff on trial and project level activities and internal processes
Key contributor or sub-team lead on global non-clinical project activities or on process improvement initiatives
Key solution provider on technical subjects or processes, also effectively implementing solutions with a team. Guide others in independently handling issues and problem solving
Operationally manage a team of 3-10 associates including setting yearly objectives and monitoring delivery on projects
Provide input to group head on performance and development planning of team members. 12.Deputize GH on operational tasks and QA of deliverables
Expert knowledge and experience with SAS preferred intermediate knowledge of Biostatistical concepts and software (S+, R) for Bios role
Good understanding of global clinical trial practices, procedures, methodologies
Good understanding of regulatory requirements relevant to ONC Biometrics (e.g. GCP, ICH)
Ability to develop and coach members Oncology Biometrics team. 7.Demonstrated ability to take responsibility for deliverables
Problem solving abilities, with subsequent issue handling demonstrated

153

Statistical Programmer Resume Examples & Samples

Performs data management
Assembles data from multiple sources, resolves data problems and performs general data management tasks with Minimal supervision and/or mentoring
Demonstrates ability to work with data from multiple platforms
Develops, writes, documents and tests statistical programs given the parameters and/or someone's sample code
Delivers code that requires minimal review and cross checking from a more senior individual and should use advanced programming methods, such as macros or reusable functions, advanced SQL, etc
Uses and adapt programs of others and document your own code
Demonstrates basic ability to interpret bio-statistical, epidemiological, or general research results
Demonstrates ability to effectively communicate both verbally and in writing to other team members
Provides review or revisions may be necessary in outside communications
Trains and mentors Statistical Programmer I's and/or serve as department technical resource
Demonstrates ability to draft basic statistical programs
Knowledge of SAS or S-PLUS/R is required
Knowledge of SQL, Oracle or other relational database preferred
Understand basic medical terminology
Demonstrates basic ability to interpret biostatistics, epidemiological, or general research results

154

Statistical Programmer Resume Examples & Samples

Programs tabulation datasets and statistical analyses (via analysis datasets, tables, figures, listings, etc.) using an appropriate statistical analysis systems (i.e. SAS®)
Serves as a key member of project team by attending team meetings and working with biostatistician data managers and project managers
Performs qualify review of tabulation datasets, analysis datasets and TFL programs developed by other programmers and biostatisticians
Performs programming using techniques such as macro language, advanced data manipulation and statistical procedures
Demonstrates knowledge of computer programming, statistical analysis systems (SAS), and other procedural languages
Understands clinical informatics procedures, workflows and software systems
Displays ability to manage extremely large datasets for statistical analysis and mathematical model creation
Exhibits excellent written and oral communication skills
Demonstrates a good understanding of tabulation and analysis data structure standards (SDTM, ADaM)
Demonstrates leadership skills in the coordination of statistical programming projects
At least 2 years of statistical programming experience

155

Senior Statistical Programmer Resume Examples & Samples

Assurance of deliverable quality and process compliance
Effective deliverable development utilizing global and TA standards that optimize analysis and reporting and promote a strategic knowledge-base data model
Maintaining and managing a project plan including resource forecasting
Coordinating the activities of a global programming team that includes outsource provider staff
Membership on departmental strategic initiative project teams such as new statistical computing platform evaluation and development
B.S. in Statistics, Applied Math/Economics, or related field with (5) years SAS programming experience in a Clinical Trial environment completing statistical programming deliverables for Clinical Study Reports

156

Senior Statistical Programmer Resume Examples & Samples

Knowledge of the programming and reporting process,
Strong leadership ability Ability to successfully work together with a (“virtual”) team (including international teams as required) as well as independently
Good business awareness/business development skills (including financial awareness) Work effectively in a quality-focused environment
4+ years of experience doing strong hands on experience in TLF, SAS coding, Macros, SQL, PROC reports, SDTM, ADAM,HARP, safety reports, efficacy reports

157

Statistical Programmer Analyst Resume Examples & Samples

Prepares and distributes summarized information to clinical study team members
Recommends technical and process solutions that can be used or developed to increase efficiency of project work
Provides technical solutions to a wider range of problems with higher level of complexity. Independently determines and develops approach to solutions. Adapts to changing circumstances, policies, work assignments, and/or team members
Considers strategies that will allow consistency or continuity of subsequent tasks (e.g., multiple studies in an ISE or ISS)
Contributes to the development of department-level standards, tools and templates
Determines technical objectives and direction for project(s). Develop timelines for SPA component of the study
Proactively addresses project uncertainties to minimize risk and alerts or escalates the issue to the appropriate person (project team member, Lead SPA, or management). Identifies, communicates and overcomes technical and interpersonal obstacles
Negotiates effectively within project teams and working groups for reasonable timelines and scope, also negotiates alternative timelines based on resourcing / priority constraints
Leads statistical programming activities of a set of studies or indication
Contributes to user aspects of technical infrastructure or business process initiatives with a focus on statistical programming, data process and analysis reporting procedures

158

Statistical Programmer Analyst Resume Examples & Samples

Builds and maintains effective working relationships with cross-functional teams. Builds mutual purpose with team members
Negotiates alternative timelines based on resourcing / priority constraints
Contribute to user aspects of technical infrastructure or business process initiatives with a focus on statistical programming, data process and analysis reporting procedures

159

Senior Statistical Programmer Resume Examples & Samples

Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers, including the Clinical Trial Team, Lead/Trial Statistician and the operational manager
Adequate representation of the Statistical Programming function as Trial Programmer in the Clinical Trial Team, Data Review Team and BDM Project Team – effectiveness of communication and team behaviors as assessed by the team members
Ability and effectiveness in training, mentoring and coordinating internal and external programmers assigned to the same study as assessed by the operational manager

160

Senior Statistical Programmer Resume Examples & Samples

Generates analysis datasets including documenting variable specifications, statistical summary tables, listings, figures and reports mainly using SAS
Handles SAS programming issues of varying complexity and performs quality control check of SAS programs. Develop SAS macros, templates and unitlities for data cleaning and reporting
Works with Biostatistician, Biostatistics Manager, and Clinical Project Team to develop scientifically sound clinical study designs and contributes to the CRF development to meet protocol requirement
Provides input to database requirements for EDC studies and assists with UAT of data transfer files
Contributes to or prepares statistical analysis plans (SAP) under the direction of Biostatistician or Biostatistics Manager
Implement analyses specified in the protocol or SAP under the direction of Biostatistican or Biostatistics Manager
Prepares template and performs programming for periodic progress reports for assigned clinical programs
Perform quality control on final reports
Compiles clinical data and relevant background material, and presents these results to the Biostatistician and Biostatistics Manager for review
Bachelor’s degree or higher from an accredited university
Minimum of one (1) year of prior professional experience analyzing datasets
Master’s degree level of education in Statistics, Biostatistics or related field
Five (5) of experience working with clinical data
Experience in medical device, biotechnology or pharmaceutical industries
Proficient programming skills in SAS, R or SPlus; experience using SQL and EDC highly desirable
Strong interpersonal and customer-focused skills; exceptional ability to drive results through strong collaborating and influencing skills across all business segments and geographies
Demonstration of strong oral and written communication skills
Working knowledge and understanding of medical coding, including ICD, CPT, DRG, etc
Ability to provide guidance to colleagues and senior management in innovative statistical techniques

161

Senior Statistical Programmer Resume Examples & Samples

Collaborates with Biostatistics, Data Management and Clinical Operations in the design and development of protocols, statistical analysis plans, data management plans, and ensures programming integrity and compliance for data analyses and the reporting of results
Prepares statistical programming components of regulatory submissions
Is a highly skilled programmer who performs highly-complex programming, reviews Statistical Analysis Plans and Case Report Forms (CRFs), creates statistical report templates, and contributes to statistical programming standards
Understands the clinical data acquisition and processing services provided by vendors to HeartWare
Helps to define the internal process for validating and distributing data within the company and maintains a record of the source of distributed data for later confirmation if necessary
Ensures integrity and regulatory compliance of all data analysis associated with in-house and outsourced clinical study databases, software, and raw analysis data files
Contributes to the preparation of SOPs relevant to statistical programming and validation
Knowledge of the infrastructure and operational characteristics of contract research organizations Candidate must be highly motivated, have excellent interpersonal and written communication skills, composed under stress and well organized
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers

162

Senior Statistical Programmer Resume Examples & Samples

Participate in building the design of a clinical trial phase I protocol
Write and review the statistical analysis plan for phase I trials
Develop Table Shells and specifications on CDISC ADaM datasets
Program and validate the statistical analysis, possibly in co-operation with other Biostatisticians and/or Statistical Programmers
Communicate to the Data Manager on database topics to guarantee reliable conclusions
Create high-quality graphs for visualization of data and analytic results
Work in close collaboration with the Biostatistical Coordinator and other colleagues

163

Statistical Programmer Resume Examples & Samples

Utilize SAS and other applicable data/analytical tools (e.g. SQL/Excel) to extract and analyze data
Cleaning and merging multiple large data sets
Conduct descriptive analyses based on needs of the project
Summarize complex data to easy to read formats
Ability to interpret data
Act as a data consultant
Present data to a non-technical audience
3+ years of data analysis and SAS programming experience in Healthcare industry or related field
Excellent reporting skills in developing requirements and interpretation of reporting data
Expertise with MS Excel (pivot tables, advanced formulas and functions)
Proficiency in Microsoft Office applications
Experience with medical and pharmacy administrative claims data

164

Statistical Programmer Month Contract Resume Examples & Samples

Utilize BI SOPs and guidelines, trial and project documentation to support the programming requirements of the Medical Quality Review Plan (MQRP), the Trial Statistical Analyses Plan (TSAP) and other supporting reports for trials of Phase I - IV
As a PPROG or PPROG-TMCP, provide support for the electronic submission to regulatory agencies worldwide. This may include the preparation of TMCP analyses or safety and efficacy analyses datasets, data files, application programs, and electronic documentation and user manuals. Perform validation activities to ensure the quality of the submission. Keep abreast of international data standards (e.g. CDISC) and supply programming support to the project team to accomplish this requirement from the regulatory authorities
Transform specifications in the Project and Trial Statistical Analyses Plans (P/TSAP) into fully documented and tested programs supporting both safety and efficacy displays and Analyses Data Sets (ADS) required for the Clinical Trial Report. This includes: standard displays that require complex data building programming prior to the call of a standard macro; moderate to complex safety displays that cannot be produced by the use of a standard macro; efficacy displays that require applied statistics knowledge in order to produce well documented tested efficacy programs; and the creation of Analyses Data Sets (ADS) that may require the application of statistical methods; implementation of tables as specified in the MQR plan. Reviews the TLFs across the displays for consistency prior to review by the statistician
Provide support for the electronic submission to regulatory agencies worldwide. This may include the preparation of safety and efficacy data files, application programs, and electronic documentation and user manuals. Performing validation activities to ensure the quality of the submission. Keep abreast of CDISC/ADAM international data structures and supply any programming support to the project team to accomplish this requirement from the FDA
Help maintain libraries of fully documented and validated programs, macros and procedures which can be reused by other programmers to aid the department's overall efficiency
The PPROG develops a project programming strategy with the PSTAT and PDM, involving the trial teams as well. Define critical steps and decisions to be made to enable timely reporting in phase III on trial and project level. Implement project programs as much as possible and enable usage across trials
Represents the Statistical Programming function on multi-disciplinary, international working groups, with the ability to lead international working groups
Helps create or provide training materials in supported area
Communicate and collaborate with the CRO programmer when part of the trial programming or double programming is outsourced, providing any necessary oversight
Proactively propose effective and efficient implementation methods of TMCP related statistical aspects. Translation of statistical analyses of Clinical Pharmacology (CP) and Biomarker (BM) data on trial and project level into programming code using R and SAS. Support the statistical implementation TMCP parts of submission package (e.g. integrated & meta-analysis of PGx, BM, PK/PD) & exploratory data analysis of TMCP trials. Support the development of TMCP specific programming tool box, e.g. clustering, re-sampling, simulations

165

Statistical Programmer Resume Examples & Samples

Utilize BI SOPs and guidelines, trial and project documentation to support the programming requirements
Of the Medical Quality Review Plan (MQRP), the Trial Statistical Analyses Plan (TSAP) and other supporting reports for trials of Phase I - IV
Gain specific knowledge about the clinical data collected for the trial. Attend trial meetings as necessary (e.g. Trial Preparation Meeting, Medical Quality Review Meeting, and Blinded Report Planning Meetings). Communicate with other trial team members as needed. Keep management abreast of critical process issues, resource shortages and changes in timelines
Review and provide feedback to the trial statistician regarding the scientific portion of the statistical analyses plan and the shell mock-ups for completeness, correctness and adherence to cited department guidelines and SOPs. Author or co-author the Analysis Data Set (ADS) specification with the statistician. Challenge the Technical TSAP to ensure the most standardized and efficient processes can be used for its implementation. Ensure programming issues are resolved and specifications are kept updated in the SAP. Communicate and collaborate with the CRO programmer when any part of the programming is outsourced
Transform specifications in the Trial Statistical Analyses Plans (TSAP) into fully documented and tested programs supporting both safety and efficacy displays and Analyses Data Sets (ADS) required for the Clinical Trial Report. This includes: standard displays that require complex data building programming prior to the call of a standard macro; moderate to complex safety displays that cannot be produced by the use of a standard macro; efficacy displays that require applied statistics knowledge in order to produce well documented tested efficacy programs; and the creation of Analyses Data Sets (ADS) that may require the application of statistical methods. Reviews the TLFs across the displays for consistency prior to review by the statistician
Provide fully documented and tested programs utilizing project or substance data bases in support of integrated reporting for regulatory agencies, Investigator Brochures (IB), etc
Reviews TLFs for consistency across displays prior to sending package to the statistician
As a Co-PPROG or co-PPROG-TMCP support the project programmer in analyses activities to support submissions. Examples could be validation programming, quality control of finalized outputs, or draft authoring of project ADS plans

166

Statistical Programmer Resume Examples & Samples

As required, make certain that documents and specifications are consistent and comply with company standards for specifications of analysis datasets, listings, summaries, fig-ures and tables for phase I – IV clinical trials. 3.Program, according to specifications, analysis datasets, listings, tables, and figures or phase I-IV clinical trials and/or apply standard statistical methods (as Reporting Statistician in Phase I) to standardized PK study designs
Track clinical trial milestones for ONC Biometrics deliverables
Comply with pre-defined project / study standards and specifications
Working knowledge and experience with SAS preferred

167

Senior Statistical Programmer Resume Examples & Samples

On a Division-wide level instructs clinical researchers, fellows, and research project programmers regarding statistical data analyses and data management
Oversees work of the UNIX network system analyst
Conducts sophisticated statistical analyses and collaborates with clinicians and senior statisticians in developing models and writing abstracts and manuscripts
Write complex programs using SAS® and SUDAAN®, as well as other statistical and analytical software packages and languages including UNIX and SQL. Ensure code is re-usable for subsequent analyses
Manages multiple projects simultaneously and resolves difficulties in coordination of data with multiple sources
Develops and presents macro programs implementing complex statistical algorithms to be used by clinical researchers, fellows and students of HSPH
May provide daily teaching assistance in statistical programming and statistical methods for summer courses coordinated through the Harvard School of Public Health
Provides the division with information about up-to-date technology producing the most efficient data management systems
Documents programming and data management issues
Performs other duties and responsibilities at the supervisor’s request
Master’s required in health sciences related field, preferably biostatistics
Five to ten years in a programmer/analyst position in the health care environment strongly preferred
Strong knowledge of SAS and SUDAAN programming and statistical analyses required
Experience with hierarchical models (particularly using mlWIN software) highly desirable
Must be deadline oriented, be able to multi-task, and communicate effectively
Excellent communication skills-both oral and written
Demonstrated statistical/analytical and reasoning skills to perform high level problem solving
Has thorough understanding of analysis, coding, testing and project methodologies
High level of confidentiality must be maintained

168

Principal Statistical Programmer Resume Examples & Samples

Import/export programming
Data listings
Demonstrate strong organizational skills and ability to manage activities related to their assigned task
Coordinate study programming activities with peer staff

169

Associate Statistical Programmer Resume Examples & Samples

Be part of project teams and will be supporting analysis and reporting on HTA projects. HTA projects supported by the team will consist in (re-)using clinical trial data to derive HTA analysis datasets and deliver Tables, Figures and Listings (TFLs) in support of HTA dossiers
Collaborate with more senior programmers and the HTA statisticians to gather and interpret the requirements
Access and gather the required data before transforming them into HTA analysis datasets
Ensure efficient and SOP compliant delivery of flexible FTLs reporting tools mostly using the SAS programming macro language

170

Senior Statistical Programmer Resume Examples & Samples

Develop and comply with project / study standards and specifications following internal guidelines
Program and deliver, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for clinical trials with high quality and within milestones
As required, make certain that documents and specifications are consistent and comply with company standards for specifications of analysis datasets, pooled datasets, listings, summaries, figures and tables for clinical trials
Support quality control and quality audit of deliverables
Participate in the selection of CROs and supervise the trial activities of the CROs as needed
Working knowledge of database design/structures
Good understanding of regulatory requirements relevant to SR (e.g. GCP, ICH)
Intermediate knowledge of office tools
3 - 5 years’ experience in a programming role preferably supporting clinical trials/ or in the pharmaceutical industry

171

Associate Principal Statistical Programmer Resume Examples & Samples

Excellent interpersonal skills and ability to negotiate and collaborate effectively
Excellent English written, oral, and presentation skills
Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders
Significant expertise in SAS and health care programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise
Ability to comprehend data analysis plans which may describe observational research and statistical methodology to be programmed; understanding of observational research or statistical terminology and concepts; implements observational methods not currently available through commercial software packages
Unix operating system experience; SQL experience; systems and database experience

172

Statistical Programmer Resume Examples & Samples

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Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming
Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to
Be trained in sponsor WSOP’s and disseminate knowledge to project team members as

173

Senior Statistical Programmer Resume Examples & Samples

As Senior Statistical Programmer, you will provide critical clinical programming support to projects. You will proactively keep the manager updated on the status, programming accomplishments and criticality of any issues impacting the quality and timely delivery of statistical Programming outputs, as well as actively solicits feedback from manager to address any issues and/or complex problems. You will provide oversight for programming deliverables performed by MedImmune’s functional service provider. You will independently implement and champion the use of standards and TA specific data listings, summary tables, and figures as specified in statistical analysis plan in the clinical study report. You will also review and provide feedback on eCRF designs, eCRF annotations, DB structures, edit checks, SAPs and SPPs. You will ensure compliance of standards for all statistical programming assignments
Interact directly and independently with Biostatisticians, Data Management, Programmers, Clinical Development staff and management as a fully functioning member of the clinical programming team
Collaborate with external partners, ensuring partners have thorough understanding of expectations
Lead in the development of analysis data set specifications
Develop robust, flexible SAS macro programs or modules that generate standard outputs and/or facilitate CDISC implementation
Proactively offer and provide statistical programming and analytical skills that support clinical trial and/or TA projects and programs
Independently interact directly with Biostatisticians, Data Management, Programmers, and Clinical Development staff and management as the lead programmer
Efficiently coordinate activities of other SAS programmers assigned to projects
Proactively inform SAS management of the status of SAS programming deliverables, accomplishments and issues experienced and remediated on projects
Provide accurate estimates SAS programming resources to manager
Assure the compliance of standards for self and other SAS programmers assigned to projects
Create good solutions for complex requests based on experience in delivering on successful solutions
Take initiative to provide SAS programming help when needed
Provide input in the creation and revision of SAS Programming Work Instructions and Standard Operating Procedures

174

Principal Statistical Programmer Resume Examples & Samples

Support and/or lead programmer for programming and QC of analysis datasets, TFL's or standard tools following Regeneron standard data models or user requirements. Assist in the coordination of activities and communicate shifting timelines and milestones
Integration of data across studies in support of CSS/CSE. Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies
Support creation and validation of e-submission requirements (i.e. annotated CRF, data export files, define documents)
Work in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports,. If applicable, develop and provide department training for applications and standard tools developed by the department functions group
Participate in department working groups; provide input in development of tools and improvement of processes
Adheres all direct reports about the procedures surrounding retention of data, records, and information for employees in their group
Works independently, exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks
Strong SAS programming skills, preferably in a clinical data environment
Strong understanding of relational database structure
Understanding of reporting systems utilizing multiple data delivery applications
Experience with implementing standardization methodology
Demonstrated teamwork and interpersonal skills. Ability to problem solve. Strong verbal and written communication skills in a global environment
Knowledge of pharmaceutical clinical development (i.e. understanding safety deliverables, efficacy analysis) and ability to provide programming support needs for BLA and other regulatory submissions
Some experience in project management with supervision. Ability to organize and manage multiple assignments with challenging timelines for a limited number of personnel
Problem solving and innovative skills that demonstrate initiative and motivation
Ability to support multiple assignments with challenging timelines
Familiarity with the development and execution of user requirements, validation plans, operational and performance protocols
Knowledge in creation of current CDISC data structures
SAS, (Base, Stat, Macro, graph)

175

Statistical Programmer Resume Examples & Samples

Statistical Programmer III is responsible for the preparation of data utilized by Risk Analysts and Statisticians, the implementation of data models and scorecards, and the execution of User Acceptance Testing of internal systems and third-party deliverables. Senior Statistical Programmers are expected to interact with many other departments in the interest of achieving the overall company objectives
Actively participates in the development of data science tools to merge, concatenate, and verify the consistency and accuracy of data sets prepared for the data modeling team
Liaisons with the IT department in order to properly implement data models and scorecards and integrate them into existing system architectures
Executes complete User Acceptance Testing process including creation of acceptance criteria, development of test procedures, test execution, and test result archiving for internal system modifications and third-party deliverables
Researches new technologies and techniques for mathematical model implementation
Develops software tools to automate modeling activities and processes
Develops and maintains tracking procedures that will be used for scorecard monitoring
Identifies statistical programming needs and communicates them to the Director of Statistical Analysis
Periodically assesses department procedures for accuracy and completeness
Develops a thorough understanding of the firm’s operations, business model, and production systems

176

Statistical Programmer Analyst Project Lead Resume Examples & Samples

Prepares summarized information or integrated analysis environments for clinical study team members
Creates tools and solutions for partners that integrate statistical methods and data from various sources in order to help them explore and gain insight into the data and statistical algorithms of interest. These tools may also be developed to provide evidence and guidance to support decision making
Uses statistical data visualization and interactive data visualization to explore and to analyze data, and to communicate findings
Lead statistical programming activities
Assess and clarify requirements, contribute to developing programming specifications, providing statistical programming solutions and ensure their efficient implementations
Responsible for accuracy and reliability of results. Builds and monitors quality in every aspect of job activities
Has a familiarity with the types of risks associated with a study and the impact on the quality of deliverables. Implements the risk based quality control accordingly
Considers strategies that will enable a smooth transition of a study or other task, if changes were to occur (e.g. with ‘fluid resourcing’ changes)
Has programming experience with object oriented languages, experience with software design and creating graphical user interfaces and makes appropriate use of this knowledge
Has a good foundation in computer science and has strong knowledge in multivariate and computational statistics including statistical learning, dimensionality reduction and simulation
Applies his/her significant programming experience with statistical software packages such as SAS, R or Python, and software design experience with other programing languages (e.g. Java, C++, JavaScript, Tcl, Perl, …) to the problem solution within study and project teams

177

Senior Statistical Programmer Analyst Resume Examples & Samples

This role requires a working knowledge of departmental processes, clinical R&D concepts and applicable health authority regulations
A Bachelor’s degree or higher in computer science, mathematics or other scientific field (or equivalent theoretical/technical depth) is required
A minimum of 5 years SAS programming experience with increasing responsibility is required
Experience working with programmers in a team environment is preferred
Late Development CV/Met therapeutic area experience is strongly preferred

178

Statistical Programmer Resume Examples & Samples

Provides statistical programing support for assigned clinical studies or projects
Creates analysis datasets per specifications for each study
Programs customized data displays in accordance with approved statistical analysis plan and shell displays for clinical studies
Reviews table shells for clinical study reports
Writes statistical programs to generate tables, figures and listings for clinical study reports
Prepares documentation for statistical programs
Conducts data checks to ensure data integrity
Creates standard macros to improve efficiencies
Provides input on standardization of processes, programs and documentation to improve efficiencies
Conducts validation activities as assigned
Maintains current knowledge in developments in statistical programming languages (SAS)
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Bachelors in engineering, statistics or biostatistics, mathematics, or closely related field
3 to 5 years of experience in statistical programming in SAS, preferably in the medical device industry
Experience working in a broader enterprise/cross-division business unit model preferred
Ability to work in a highly matrixed and geographically diverse business environment
Ability to leverage and/or engage others to accomplish projects
Multitasks, prioritizes and meets deadlines in timely manner
Master’s degree in engineering, statistics or biostatistics, mathematics, or closely related field

179

Statistical Programmer Analyst Resume Examples & Samples

Performs statistical programming activities
Assess and clarify requirements, contribute to developing programming specifications, providing statistical programming solutions to ensure their efficient implementations
Considers strategies that will enable a smooth transition of a study or other task, if changes were to occur (e.g. with ‘fluid resourcing’ changes) in order to allow consistency or continuity of subsequent tasks
Negotiates effectively within project teams and working groups in order to ensure reasonable timelines and scope, also negotiate alternative timelines based on resourcing / priority constraints
Ensures quality of deliverables
Has a familiarity with the types of risks associated with a study and the impact on the quality of deliverables and implements the risk based quality control accordingly to ensure validity
Contributes towards technical solutions
Provides technical and process solutions that can be used or developed to increase efficiency of project work
Independently determines and develops approach to solutions to ensure issue resolutions

180

Senior Statistical Programmer Analyst Resume Examples & Samples

Adheres to departmental procedures and practices, technical and industry standards and programming concepts and conventions during all aspects of work
Builds effective working relationships with cross functional groups within BioMetrics, the study team and the company
Negotiates effectively to meet study objectives
Monitors contractor programmer project activities and reviews contractor programmer deliverables as necessary
Responsible for CDISC standard data files
Conducts program development and verification, identifies bugs and resolves technical problems
Leads the preparation and distribution of reports to the project team members
Investigates trends, identifies techniques and makes recommendations for new methods and technologies used in pharmaceutical and/or biotech industries for reporting and managing clinical data
Participates in the development of standard reporting tools or components and system utilities for the statistical programming group
Contributes to developing BioMetrics SOPs
A minimum of 6 years SAS programming and applications development experience in pharmaceutical and/or biotech company
Thorough knowledge of data collection practices and data flow
Commanding understanding of the Biometrics role in the broader clinical development setting

181

Statistical Programmer Resume Examples & Samples

Responsible for the production of SDTM datasets to the required specification
Responsible for the production of TFLs and ADaM datasets to the required specification for clinical, PK and PD reports
Responsible for leading studies, ensuring datasets, TFLs and associated documents are completed in a timely and quality manner
High level of interaction with external and internal clients on study related issues and technical matters
Provision of guidance, mentoring and training in SAS production processes and programming techniques

182

Senior Statistical Programmer Resume Examples & Samples

Deliver high quality statistical programming outputs for all assignments that consistently meet study timelines, quality standards, sponsor and/or contractual requirements
Adhere to programming specifications and study specific requirements, including completion and filing of required documentation
Plan, organize and prioritize workload to ensure effective time management and adherence to project specific timelines
Efficient use of SAS, and adherence to SAS programming guidelines
Create listing and safety outputs (analysis datasets, tables, figures) to a high standard of quality and accuracy
Validate listing and safety outputs (analysis datasets, tables, figures) per departmental procedures
Create efficacy outputs (analysis datasets, tables, figures) to a high standard of quality and accuracy
Validate efficacy outputs (analysis datasets, tables, figures) per departmental procedures
Create complex programs (such as project or departmental macros) to a high standard of quality and accuracy
Validate complex programs (such as project or departmental macros) per departmental procedures
Create and maintain analysis dataset specifications to a high standard of quality and accuracy
Set-up standard programming directories and start-up utilities
Create, document and validate macros at the table, listing and figure level
Trouble-shoot and resolve programming issues in a timely and efficient manner
Proactively communicate and work effectively with the biostatistics team including remote teams and with senior programming, management and sponsor personnel to achieve study goals
Strive for excellence and act in a proactive and responsive manner to internal and sponsor needs
Demonstrate a constructive and flexible approach to project delivery, including problem solving, handling changing priorities and meeting study timelines
Learn, share and apply new techniques and technologies to increase efficiency and to implement industry trend solutions (e.g., SDTM, ADaM)
Perform other project activities as required, including timely and accurate study file completion (electronic and paper)
Actively participate and contribute towards department initiatives, including sharing of knowledge, current literature reviews and process improvement
Preparation and delivery of presentations and attendance at appropriate scientific meetings and conferences
US/LATAM/CAN: A minimum of 8 years relevant experience of successfully performing the role of Statistical Programmer, preferably in the clinical research industry
Prior experience of leading a programming team to manage timelines, resources and overall quality in a client-facing capacity (project leadership track only)
Demonstrated ability to perform assigned tasks independently and as part of a team
Demonstrated ability to successfully manage complex assignments, including competing tasks and timelines
Ability to liaise successfully with team members, management and externally with vendors and sponsors, as required
Advanced problem solving and organizational skills, attention to detail, verbal and written communication skills
Good understanding of global clinical trial practices, procedures, methodologies and regulatory requirements (e.g., GCP, ICH)
Strong working knowledge of the types of risks associated with a study and the impact on key parameters, such as study timelines (project leadership track only)
Demonstrated ability to learn new applications and techniques
Advanced working knowledge of statistics and statistical software packages, including SAS
Advanced working knowledge of statistical concepts
Advanced/expert-level (project leadership/technical track, respectively) working knowledge of data structures (e.g., CDISC SDTM, ADaM), software development lifecycle and their implementation
Advanced/expert-level (project leadership/technical track, respectively) working knowledge of the development and use of standard programs and macros
Strong/outstanding (project leadership/technical track, respectively) SAS programming skills
Ability to critically review data and implement corrective action steps effectively

183

Statistical Programmer Resume Examples & Samples

Coordinate with the Information Systems Section and protocol programmers to provide/transmit access to internal and external clients, with documentation, to Atlas (a secure internet data portal)
Write and/or modify programs to respond to ad hoc requests from statisticians
In support of validation efforts, develop and document testing procedures, work with other statistical programmers, protocol programmers, and DAU staff to perform testing for statistical programs that produce analysis datasets, reports, and TFLs
Create graphical presentations of simple and complex data results and procedures
Provide support to statisticians, in conjunction with Laboratory Data Operations staff, for analysis of assay and lab data
Provide training and mentoring for new staff. Share expertise and knowledge of past experience to inform current and future work
Represent statistical programmers on SCHARP committees, subcommittees, working groups and special projects
M.S. in a computing, mathematical, statistical or a related field with 4 years experience programming with advanced SAS skills, including strong reporting and macro development abilities. B.S. in a computing, mathematical, statistical or a related field with at least 5 years experience programming with advanced SAS skills, including strong reporting and macro development abilities will be considered Must be able to use Perl or other scripting languages for text manipulation and automated job control. Experience in programming support of clinical trials, statistical programming in a clinical research setting or other health research programming support
Knowledge of R (graphics experience) and other programming languages desirable. Experience in relational database design and implementation a plus
Must be interested in clinical and laboratory assay research, programming and statistics
Experience programming in a scientific/research setting a plus. Familiarity with laboratory data and data management a plus
Must be flexible, work well within a team environment, and be capable of meeting tight deadlines
Must be organized and detail-oriented, with excellent oral and written communication skills

184

Principal Statistical Programmer Resume Examples & Samples

Perform, plan and co-ordinate the development, implementation and validation of new process technologies, macros and applications
Fulfill project responsibilities at the level of assisting lead biostatistician for single, complex or group of studies
For complex or group of studies, work as lead programmer
Provide expert review of process with regard to programming standards and validation procedures
Excellent SAS programming skills
Strong knowledge of SDTM and ADaM.standards
Good knowledge of SAS Macros
Knowledge of cross-over designs and pharmacokinetic data required
Effectively handle multiple tasks and projects
Ability to handle complex programming and have strong Lead Programmer experience on studies
Good understanding of leading end to end projects

185

Principal Statistical Programmer Resume Examples & Samples

As the Lead Statistical Programmer, directs the programming activities of other programming personnel, and monitors progress on programming deliverables
Participates in sponsor meetings, kickoff meetings, and bid defense meetings as Statistical Programming representative
Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and Statistical Programming management and completes project programming activities within timeframe allotted
Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in processes. Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements. Serves as a technical expert resource to other department members for complex programming questions
Works cooperatively with other Biostatistics and Statistical Programming personnel to establish Standard Operating Procedures (SOPs), guidelines, policies, and/or procedures; contributes technical expertise to the development of programming tools and macros for standardization and efficiency
Extensive experience in SAS programming in a clinical trial setting or equivalent combination of education and experience
Experience at a Principal level with SDTM, ADaM and TLF preferred

186

Senior Statistical Programmer Resume Examples & Samples

Designs and develops statistical programs for the assigned project
Performs quality control in support of clinical R&D analysis and reporting
Assists in the review and input into project requirements
Maintains documentation as appropriate
Mentors, trains junior programmers
This role requires an in-depth knowledge of SAS programming
Bachelor’s degree or higher in computer science, mathematics, health statistics or other scientific field (or equivalent theoretical/technical depth) is required
Minimum of 6 years (for bachelor)/3 years (for master) SAS programming experience with increasing responsibility, preferably in a pharmaceutical/clinical trial environment, is required
Demonstrated written and verbal communications skill is required
Expert knowledge of SAS programming. Knowledge of other statistical software (e.g., S-Plus, R, PASS) is preferred
Good communication skills in written and oral English1700179871W

187

Senior Statistical Programmer Project Gifts Resume Examples & Samples

Completes programming tasks of medium to high complexity
Critically reviews requirements and data, identifies gaps, suggests solutions and applies expertise on clinical R&D statistical programming activities
A Bachelor’s degree or higher in Computer Science, Mathematics or other scientific fields is required
In-depth knowledge of SAS statistical software with a minimum of 5 years SAS programming experience with increasing responsibility is required
Experience in a pharmaceutical/clinical trial environment is preferred
Prior experience with any of the following Therapeutic Areas is preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases and Vaccines
A working knowledge of Statistics is required

188

Principal Statistical Programmer Resume Examples & Samples

Knowledge of relational databases
Excellent organizational, interpersonal, communication skills and multi-tasking abilities
Experience managing projects budgets and timelines
Resource Management experience a plus
Able to debug and resolve code independently
Ability to adapt and adjust to changing priorities
Ability to provide direction to assigned programmers
Understanding of FDA/ICH guidelines
Minimum of five years of statistical programming in a clinical trial environment (i.e., pharmaceutical, biotechnology, and/or contract research organization industries)
Strong knowledge in developing SDTM and ADaM datasets
Strong knowledge in the creation/production of tables, figures and listings (TFLs)

189

Senior Statistical Programmer Analyst Resume Examples & Samples

A Bachelor’s degree or higher in Computer Science, Mathematics or other scientific fields is required. Advanced degree with a minimum of 3 years SAS programming experience is preferred
Knowledge of SAS macro language and SAS Graph is desired
Knowledge and experience in SDTM and ADaM is required

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