Provide technical support and expert advice to internal staff and external sponsors.
Lead projects for Statistical programming activities using SAS and R, including assigning programming tasks to different team members, monitoring quality, timelines, resource allocation, and productivity in relation to budgets.
Provide oversight and guidance on complex trials and submission projects (including Integrated Summary of Safety or Efficacy).
Assist in the review of statistical analysis plans and TLF shells; create and/or review the ADaM and SDTM dataset specifications, CRF annotation, and other process supporting documents.
Produce and/or QC derived datasets, tables, figures and data listings.
Understand regulatory requirements concerning industry technical standards (e.g., CDISC, electronic submissions, etc.) and implications for the department.
Create SAS macros and template programs s to improve the efficiency of SAS and R programming activities.
Mentor statistical programmers.