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.
• 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)
• 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.
• 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).