R Programming Lead (Statistical Programming)
On-siteReading, England, United Kingdom
Job Summary
Develop internal and external R packages for clinical trial analysis, including ADaM, tables, figures, and listings. Validate R packages and build complex R-Shiny applications to address clinical questions and EU JCA requirements. Conduct statistical programming of clinical data and create safety and efficacy study outputs consistent with CDISC standards and study documentation. Lead implementation in R and train other Biostatistics team members while identifying problems to develop global tools that increase group efficiency. Collaborate with peers and statisticians to ensure submission readiness of clinical data for authorities.
Required Qualifications
- Strong experience in R programming for clinical trial data including developing and validating R packages from CRO or Pharmaceutical Industry
- Strong programming skills in R/R Shiny
- Proven experience in applying R and R-Shiny for the analysis and reporting of clinical trials
- Ability to reproduce statistical analysis using R
- Strong skills in data visualization and data wrangling using R
- Proficiency in using R packages for data exploration and visualization
- Application of statistical methodology and concepts in clinical trial analysis
- Experience with R-Shiny apps for data exploration
- Advanced knowledge of industry standards including CDISC data structures
- Solid understanding of the development and use of standard programs
- Ability to conduct statistical programming of clinical data using R
- Ability to create/validate safety and efficacy outputs (ADaM, TLFs) aligned with study documentation (protocol, SAP, aCRF)
Desired Qualifications
- Exposure to Late Phase, Real-World Evidence (RWE) & Global Medical Affairs studies is highly desirable
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