Manager, Statistical Programming Job Description
Manager, statistical programming
provides expert review of process and methodology development work with regard to programming standards and validation procedures.
Manager, Statistical Programming Duties & Responsibilities
To write an effective manager, statistical programming job description, begin by listing detailed duties, responsibilities and expectations. We have included manager, statistical programming job description templates that you can modify and use.
Sample responsibilities for this position include:
Development of detailed programming strategy and planning of programming deliverables for the assigned project
Ensuring quality and on-time deliverables in compliance with departmental processes
Develop an expertise within a therapeutic area or standard tool
Check quality of team deliverables (e.g., on site visits, Central File documentation) and take
Participate in CRF design, database review, data management plan, data review, data validation procedures, and review of data listings
Design, develop, implement, and maintain software for the monitoring of ongoing studies, reporting, and analysis of clinical trials
Provide consistency across protocols within a project on CRFs, database design, analyses files, and tables, listings, and graphs
Produce data listings, summary tables and graphics for interim and final analyses and publications
Create statistical files for statistical analysis
Provide consulting and systems support for applications software
Manager, Statistical Programming Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Manager, Statistical Programming
List any licenses or certifications required by the position: SAS, STAT
Education for Manager, Statistical Programming
Typically a job would require a certain level of education.
Employers hiring for the manager, statistical programming job most commonly would prefer for their future employee to have a relevant degree such as Master's and Bachelor's Degree in Computer Science, Statistics, Mathematics, Biostatistics, Technical, Life Sciences, Health, Computer Sciences, Education, Graduate
Skills for Manager, Statistical Programming
Desired skills for manager, statistical programming include:
Excel
Outlook
Relevant software: Windows
Word
Clinical drug development process
Statistics
Additional programming languages
Clinical tests
Clinical trial methodology
Drug development process
Desired experience for manager, statistical programming includes:
Experience overseeing the work of internal contractors and possibly external vendors (CROs)
Minimum of 7 years of experience in developing software to analyze clinical data using the SAS system
Participate in PXL and department system/standards improvement activities
Support efforts for generating business leads (client networking, public speaking)
Ability to successfully work together with a (“virtual”) team (including international teams as required) independently
Coordinate data transfer and/or programming standards with CROs and vendors
Manager, Statistical Programming Examples
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Manager, Statistical Programming Job Description
Job Description Example
Our company is searching for experienced candidates for the position of manager, statistical programming. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manager, statistical programming
- Responsible for execution of ad-hoc requests, manuscripts, posters, and presentations
- Support and provide technical guidance to SPT organization as required, Drug Development Team, GBS Planning & Execution Leads, Statisticians, Statistical Programmers and vendors
- May, if required, manage an assigned group of Statistical Programmers to establish employees’ objectives and manage their performance
- Ensures quality of GBS deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs and work practices
- Provides comprehensive programming leadership and support to clinical project teams, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, corporate and departmental SOPs and work practices
- Drives the development and implementation of innovative strategies and technologies for clinical trial programming
- Provides technical guidance to vendors concerning project standards, programming conventions/specifications and programming practices to ensure efficient and integrated project computing strategies
- Reviews planning documents
- Develops unambiguous and robust programming specifications for internal and external programming work
- Independently develops, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and BMS standards
Qualifications for manager, statistical programming
- Expertise in SAS programming language (especially data step, and summarization procedures), report generation, and standards for programming and validation
- Experienced in macro writing
- Experience with CDISC data standards required
- Experience as a senior statistical programmer level in a pharmaceutical or CRO working in a FDA regulated environment
- Experience with Clinical Study Reports and NDA submission
- Understanding of regulatory guidelines that affect statistical deliverable
2
Manager, Statistical Programming Job Description
Job Description Example
Our company is hiring for a manager, statistical programming. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manager, statistical programming
- Identifies opportunities for increased efficiency and consistency within GBS and provides SME support to continuous improvement initiatives within and beyond GBS
- Builds successful partnerships and seamless interfaces within the department and the broader research and development organization
- Leads the statistical programming support on a defined portfolio of clinical projects at RSS
- Provides programming support for projects, including development of programming and validation strategies and plans, specifications and programs for planned and ad-hoc exploratory analyses
- Ensures quality deliverables by consistently complying with regulatory requirements, guidance and corporate and departmental policies and procedures
- Establishes and maintains effective interfaces with cross-functional partners and works collaboratively with multiple stakeholders to manage priorities and resources
- Presents effectively statistical programing concepts, assessment of risks and impacts and logical arguments to statisticians and other cross-functional team members
- Provides strategic input on the development of CRFs and database designs
- Reviews and provides input to planning documents
- Establishes and ensures adherence with programming and output standards and utilization of systems and processes to maximize efficiency of statistical programming function
Qualifications for manager, statistical programming
- Ability to work on multiple tasks simultaneously and meet project deadlines
- At least 6 years clinical/statistical programming experience within pharmaceutical clinical development including support of significant regulatory filings
- Broad expertise in statistical programming and developing computing strategies for statistical analysis & reporting
- Expert knowledge of Base SAS and advanced knowledge of SAS Stat and Graph
- Management experience supervising technical professionals
- US military experience will be considered towards industry and professional experience requirements
3
Manager, Statistical Programming Job Description
Job Description Example
Our growing company is hiring for a manager, statistical programming. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for manager, statistical programming
- Participates on multidisciplinary project teams
- Consistently achieves individual goals as set with manager
- The Statistical Programming effort provides a major component of the statistical summarization of each clinical study and of the accumulated data supporting a new drug candidate as it reduces the volume of data to concise data listings and summary tables needed to interpret the results
- FDA regulations require the submission of data files, data listings, and summaries in electronic formats
- SAS is the only format currently accepted by FDA for the submission of the data
- Provide ongoing supervision, advice and consultation to the Lead Programmers and the rest of the programming team to ensure timely and efficient completion of projects
- Provide input and review of new business proposals, including time and cost estimates and associated documentation
- Work as a statistical programmer on drug development project teams
- Programming of ad hoc requests for exploratory analyses and time-sensitive deliverables
- Identify and establish secured computing/analytical environment, programming standards and practices to ensure alignment between programming strategic direction and company’s R&D strategies
Qualifications for manager, statistical programming
- Experience in pharmacokinetics/pharmacodynamics modeling a plus
- Knowledge of relevant internal and external standards and guidance for clinical development (CDISC, EMEA/FDA, ICH- GCP )
- In-depth knowledge of applicable clinical research regulatory requirements
- Master's degree in computer science or related field and 5 years relevant experience including 1 year in a leadership capacity
- In-depth knowledge in industry data standards and regulatory data submission requirements, with a focus on ADaM data standards and eSub data package
- Candidates must demonstrate thorough knowledge of SAS by successful completion of the SAS core certification test for version 9 SAS (SAS Certified Professional V6) or an equivalent means
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Manager, Statistical Programming Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of manager, statistical programming. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for manager, statistical programming
- Manage and work directly with CROs used for clinical/statistical programming
- Oversee the development, review, validation, and execution of SAS programs to generate
- Ability to manage and participate on multiple project teams simultaneously
- Attention to and accuracy with details
- Must enjoy working with people and fostering a strong sense of teamwork
- Ability to adapt to new processes and environments quickly and in a positive manner
- Ability to spend significant time creating and clearly refining project and design documentation
- Coordinate and participate in process improvements and interoffice/interdepartmental task forces
- Advanced knowledge and experience with SAS programming (SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/SQL, SAS/ODS Modules)
- Excellent knowledge on CDISC standards (CDASH, SDTM, ADaM, eSub) and Implementation Guidelines, Create/Review Define Docs, Reviewers Guides, OpenCDISC validation report Assists in submissions of electronic SAS datasets to regulatory agencies
Qualifications for manager, statistical programming
- Project lead experience required
- At least five years’ of relevant experience, or a PhD and at least three years’ experience working with and analyzing big data
- Substantial knowledge of all aspects of clinical trials from initial study set-up to study completion
- An excellent understanding of the roles and responsibilities of all related disciplines, Biostatistics and Clinical Data Management
- Good interpersonal skills and the ability to communicate appropriately with all levels of staff throughout the global organization and confidently with other disciplines and external clients
- 10+ years of clinical/statistical programming experience in the Pharmaceutical/Biotech industry or CRO
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Manager, Statistical Programming Job Description
Job Description Example
Our growing company is looking to fill the role of manager, statistical programming. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manager, statistical programming
- Develop/review TLFs shells and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues
- Collaborate with Data Managers to provide input on CRF design, CRF annotation, edit checks, integrated data review plans, and SDTM specifications as needed
- Contribute to the development of departmental programming SOPs and implement Good Programming Practices
- Experience in integrating datasets across multiple clinical studies (or equivalent) to support ISS/ISE
- Review or contribute to study protocols, statistical analysis plans (SAPs) and TLF shells, data analysis and CSRs in collaboration with Biostats, DM and other functions
- Accountable for the quality and timely delivery of datasets and displays required for any programming deliverables they may contribute to
- Direct and coordinate statistical programming activities and assign staff to project teams
- Coordinate timelines and allocate and resources for all programming activities for direct reports
- Bachelor’s degree in quantitative or scientific discipline
- This role reports to the Statistical Programming Lead and will be responsible for leading others
Qualifications for manager, statistical programming
- Extensive experience managing CROs or FSPs to scale up or down as the workload permits
- Solid experience with global clinical trial practices, procedures, and methodologies
- Thorough understanding of clinical trial design and reporting process, regulatory reporting requirements including electronic data submissions and CDISC implementation
- Think strategically and add value by bringing unique insight to team
- Knowledge of other programming languages
- Minimum of 5 years of statistical programming in a clinical trial environment