Join a sponsor-dedicated team and contribute to the advancement of in-house study activities over time. As the R Programming Lead, you will provide technical expertise to the Statistical Programming team, ensuring the delivery of high-quality solutions that meet both internal and external requirements.
Responsibilities
• Develop internal and external R packages for clinical trial analysis (ADaM, tables, figures, listings).
• Validate R packages.
• Lead implementation in R and train other Biostatistics team members.
• Conduct statistical programming work of clinical data using R.
• Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
• Create and/or validate all safety and efficacy study output requirements (e.g. ADaM, TLFs) consistent with data definitions and specifications and relevant study documentation (e.g. protocol, SAP, aCRF)
• Collaborates with peers and statisticians to ensure the quality and accuracy –thus submission readiness –of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml).
Experience and Qualifications
1. Minimum 5+ years of experience in R programming for clinical trial data including developing and validating R packages from CRO or Pharmaceutical Industry.
2. Strong programming skills in R/R Shiny
3. Proven experience in applying R and R-Shiny for the analysis and reporting of clinical trials. Ability to reproduce statistical analysis using R.
4. Strong skills in data visualization and data wrangling using R. Proficiency in using R packages for data exploration and visualization.
5. Application of statistical methodology and concepts in clinical trial analysis. Experience with R-Shiny apps for data exploration.
6. Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs.
7. In-depth understanding of the phases of clinical trials and the drug development process.
8. Exposure to Late Phase & Real-World Evidence (RWE) studies is highly desirable.
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