JOB DESCRIPTION
Job title : Principal Analyst - Statistical Programming
Reports to : Operation Head – India BU
Job purpose
The Principal Analyst – Statistical Programming is responsible for leading end-to-end clinical trial programming activities including SDTM, ADa M, and TFL development in compliance with CDISC, FDA, and sponsor standards. The role requires expertise in SAS programming, regulatory submissions, data traceability, quality control, metadata preparation, and cross-
functional coordination to support successful clinical study deliveries.
The candidate will independently manage programming activities, mentor junior programmers, ensure regulatory compliance, and deliver high-quality submission-ready datasets and outputs within timelines.
Duties and responsibilities
1. SDTM Programming & Validation
- Perform CRF annotation and maintain complete traceability from raw data to SDTM datasets as per CDISC SDTMIG standards.
- Develop and validate SDTM...