Statistical Programmer Job Description
Statistical Programmer Duties & Responsibilities
To write an effective statistical programmer job description, begin by listing detailed duties, responsibilities and expectations. We have included statistical programmer job description templates that you can modify and use.
Sample responsibilities for this position include:
Statistical Programmer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Statistical Programmer
List any licenses or certifications required by the position: SAS, STAT
Education for Statistical Programmer
Typically a job would require a certain level of education.
Employers hiring for the statistical programmer job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Computer Science, Statistics, Mathematics, Biostatistics, Science, Life Science, Life Sciences, Education, Technical, Math
Skills for Statistical Programmer
Desired skills for statistical programmer include:
Desired experience for statistical programmer includes:
Statistical Programmer Examples
Statistical Programmer Job Description
- Work with non-standard datasets and databases to create study-specific Analysis datasets
- Write and maintain programs to create Tables, Listings and Graphs according to Statistical Analysis Plan
- Work closely with Pharmacometrician to create high quality data specifications
- Use statistical and graphical tools extensively to identify data issues and correct them
- Create datasets for Population PK Analysis
- Create PC and PP SDTM datasets according to specifications
- Ensure all written programming code meets internal and regulatory standards
- Write reusable code to automate routine tasks
- Provide input and participate in development of Processes and SOPs
- Work as part of consulting overall team (often global) to meet client deliverable requirements
- Demonstrated ability to work in global teams, , manage projects independently
- Must conduct activities in compliance with all relevant regulations such as ICH, GCP, and CFR, all Shire policies and procedures
- Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise
- Ensure timelines and adequate quality of data review reporting deliverables for assigned trials
- Follow processes and adhere to company- and project-specific standards, Health Authority requirements
- Comply with project/study programming standards and specifications following internal guidelines
Statistical Programmer Job Description
- Participate as required at all meetings, discussions and activities covering aspects of data review reporting on trial level activities
- Maintain efficient interfaces with internal and external customers
- Support creation and validation of esubmission requirements
- 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
- Provide programming support for simple presentations and basic statistical ad-hoc requests
- Create and/or validate ADaM data sets
- Ability to fill Primary Statistical Programmer role on projects
- Apply standard tools developed for the study or project
- Support to the development, validation, maintenance and enhancement of global macros training on the same
- Ensure quality of personal work and the work of the programming team when acting as a Biometrics Project Manager and Lead Programmer meeting completions dates with minimal supervision
- Advanced technical expertise in databases, EDC platforms, data imports/integrations
- SDTM, ADaM and TLF experience required
- Demonstrated skills in using additional software tools and applications
- Competent in written English
- Experience working with systems used within the Clinical Trial process (e.g., SAS)
- Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions, ) and implications for the department
Statistical Programmer Job Description
- Deliver high quality statistical programming deliverables for all assignments that consistently meets study timelines, quality standards, sponsor and/or contractual requirements
- Ensure high quality deliverables for assigned team members by performing quality control and review of programming outputs for accuracy and consistency
- Create analysis dataset specifications (ADaM or client-specific) to an exceptional standard of quality and accuracy
- Create, document and validate project/study-macros at the table, listing and figure level
- If desired, may supervise less-experienced statistical programmers carrying out line management responsibilities
- 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
- Programs tabulation datasets and statistical analyses (via analysis datasets, tables, figures, listings, ) using an appropriate statistical analysis systems
- Assist in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents
- Provide relevant training and mentorship to staff and project teams as appropriate
- Create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request
- SAS Certification desirable
- Works independently, exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, in accordance with existing policies and standards for application to specific problems or tasks
- Knowledge of pharmaceutical clinical development
- Competent in written and oral English and in Polish
- Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR
- Assist in the coordination of project start-up activities, including Unix/PMED project area set-up
Statistical Programmer Job Description
- Gain specific knowledge about the clinical data collected for the trial
- 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
- Provide support for the electronic submission to regulatory agencies worldwide
- Provide fully documented and tested programs utilizing project or substance data bases in support of integrated reporting for regulatory agencies, Investigator Brochures (IB)
- 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
- Potential supervision of less-experienced statistical programmers carrying out line management responsibilities
- Define and edit mock tables, listings and figures (TLFs) and analysis dataset specifications
- Design and develop new work instructions (WIs) and updates to existing WIs
- May coordinate efforts to standardize WIs or processes across studies
- 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
- 7 plus years Pharmaceutical/CRO industry and/or relevant experience as a SAS programmer supporting clinical trials for regulatory submissions
- Bachelor’s degree or higher in a computing or science related field
- Expert knowledge of CDISC terminology and architecture for both SDTM & ADaM
- Able to develop programming tools to efficiently create study specific SDTM and ADaM data sets
- Sound technical skills and communication ability, both oral and written
- Competent in SAS programming
Statistical Programmer Job Description
- Monitor project resourcing, project budgets, and identify changes in scope activities
- Ensure quality control (QC) on all process and technical activities related to derived dataset, tables, listing, and figure programming in accordance with corporate quality standards
- Develop data management plans
- Design, develop, and maintain data mappings, data rules, and data transformations to populate data warehouse with source data
- Produce data and unit dictionaries, edit checks, derivations, standard, and custom reports
- Generate datasets needed for resolution of discrepancies
- Communicate with local and external teams throughout the QC process to provide the most accurate and complete endpoint datasets needed for reporting requirements
- Ensure compliance with study documents and departmental procedures
- Verify completeness of study deliverables prior to release
- Make, document and validate data programs, pipelines, distribution plans, and storage
- Experience of working with clinical trials either in a CRO, Pharmaceutical or Biotechnology organization
- Experience working with SAS used within the Clinical Trial process
- Excellent understanding of clinical trial practices, procedures and methodologies is preferred
- 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
- Bachelor’s degree in Computer Science with minimum 7 years of experience
- OR Master’s degree in Computer Science with 5 year of experience