Senior Statistical R Programmer
Senior Statistical R Programmer
Posted on :
16-09-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
16-09-2025
Job Description
Job Description:
- The candidate will have the opportunity to help shape data and programming infrastructure drive the adoption of R in a regulated environment gain an in-depth understanding of drug development in a fast-moving industry environment and subject domain knowledge in neurodegeneration.
- The ideal candidate will have extensive experience supporting drug development and clinical study projects; will have excellent statistical programming and problem-solving skills; and will be able to function as a leader and individual contributor.
- The candidate will take the initiative to stay current on technologies and methods will champion the use of open-source software for clinical trial reporting come up with innovative solutions to challenging problems and work with Biometrics management to help set the overall strategic direction of the group.
- Lead statistical programming deliverables including: generation of data visualizations or summary reports to support internal decision making and regulatory interactions (IND/CTA filings annual safety reporting etc.); providing input for statistical analysis plans study protocols and clinical study reports; reviewing study randomization specifications; collaborating with Clinical Data Management on case report form design data review plans and external data transfer specifications; collaboration with the study team to review data and manage timelines; oversight of Biometrics CRO deliverables.
- Design develop and validate CDISC analysis data (i.e. SDTM ADaM) for use with statistical reporting code and analytics applications.
- Develop and manage reusable code for interactive data visualization exploratory analysis and statistical summaries in clinical study reports.
- Work with the Biometrics Team to establish innovative processes to ensure high data quality reporting of analysis results and analysis reproducibility.
- Support the Biometrics Team in efforts to build maintain and continuously improve an R infrastructure that is suitable for regulatory submission work.
- At minimum a bachelors degree in Statistics Biostatistics Data Science Mathematics or a related field is required.
- At least five years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development medical device development or intervention studies.
- Demonstrated ability to effectively lead projects and collaborate cross-functionally.
- Exceptional R programming skills (including tidy verse Markdown Shiny HTML widgets development of R packages working with IT staff to build R infrastructure) experience applying software development concepts well versed in reproducible research methods and proficiency in using code repositories like Git/GitHub (or similar tools) for collaboration and versioning of operational robust and well documented code.
- Able to work in a Linux/Unix environment (including shell scripting).
- Applied experience with SDTM or ADaM CDISC data.
- Demonstrated experience in creating compelling data visualizations to help teams make correct data driven decisions and effectively communicating results to team members.
- Able to demonstrate a solid understanding of statistical principles and methods used in clinical study reports or scientific publication analyses.
Employment Type
Full-time
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