Job title: Senior Principal Statistical Programmer – Clinical SAS

Reports to: Vice President - Operations

Job purpose

To lead the programming, validation, and delivery of high-quality statistical outputs for clinical trials by applying advanced SAS programming and CDISC standards, ensuring data integrity, regulatory compliance, and timely support of statistical analyses, clinical study reports, and regulatory submissions through close collaboration with biostatistics, data management, and clinical teams.

Duties and responsibilities
- Lead statistical programming activities across Phase I–III clinical trials, with robust Phase III experience.
- Develop and review Tables, Listings & Figures (TFLs), including Demographic, Safety & Efficacy (DSE) tables.
- Provide end-to-end expertise in CDISC SDTM, ADaM and TFL development.
- Develop/review SDTM mapping specifications/MDDT, ADaM specifications, Define.Xml, CRF annotations, SDRG and ADRG.
- Perform data mapping/transformation using CDISC and client-specific standards.




- Develop analysis datasets based on Statistical Analysis Plans (SAPs).
- Perform SDTM data pooling and support integrated analyses.
- Utilize SAS Base, Advanced SAS, Macro, PROC SQL, PROC REPORT and other statistical/reporting procedures.
- Handle complex ad hoc / RTQ requests within stringent timelines.
- Perform Pinnacle 21 validation and support resolution of validation findings.
- Develop independent QC/Double Programming programs and conduct comprehensive study reviews.
- Support SAP, TFL mockups, statistical reports and CSR activities.
- Manage multiple studies simultaneously and support resource allocation, estimation, tracking and utilization.
- Communicate with clients on project status, deliverables, risks and timelines.
- Mentor statistical programmers and conduct technical/knowledge-sharing sessions.
- Contribute to programming standards, process improvements and departmental methodologies.

Required Skills
- SAS Advanced Certified Program

📌 Senior Principal Statistical Programmer – Clinical Sas (Kukatpally)
🏢 Ocugen India
📍 Kukatpally