Principal Statistical Programmer

About the role

The Principal Statistical Programmer is a senior-level contributor responsible for designing, developing, validating, and maintaining statistical programming deliverables to support clinical trials and regulatory submissions. This individual serves as a technical expert on study and project teams, providing leadership in the application of statistical programming standards and regulatory guidance (e.g., CDISC, ICH, FDA).

What you'll do

• Technical Programming Leadership Lead the development, validation, and maintenance of SDTM and ADaM datasets and associated documentation
• Program complex Tables, Listings, and Figures (TLFs) for study reports, publications, and submissions
• Review and interpret statistical analysis plans (SAPs) to ensure accurate implementation in code
• Project & Study Support Serve as lead programmer on multiple studies and/or projects, coordinating efforts across internal teams and CROs
• Provide technical oversight and mentoring to junior programmers and contractors

What you need

• 7–9 yrs of experience
• Clinical research
• SAS
• Regulatory affairs
• CRO
• Quality control
• Documentation
• M.Sc or B.Tech or B.E. or B.Sc or BCA or M.Tech or MCA

Good to have

• SOP writing
• SQL