Senior Principal Statistical Programmer - Clinical SAS

Ocugen India Pvt Ltd · India

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 strong 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 Programmer
• Strong SAS Base & Advanced programming skills
• Extensive CDISC SDTM & ADaM experience
• Strong TFL programming expertise
• Significant Phase III clinical trial experience
• End-to-end SDTM → ADaM → TFL expertise
• Define.xml, CRF Annotation, SDRG, ADRG, MDDT
• Pinnacle 21 validation
• QC / Double Programming
• FDA / EMEA regulatory submission experience
• Knowledge of ICH E3, E6 & E9 and 21 CFR Part 11
• Strong leadership and mentoring capabilities

Qualifications and Experience

• Bachelor’s/master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or a related discipline.
• Strong hands-on expertise in end-to-end SDTM → ADaM → TFL programming, regulatory submission deliverables, statistical reporting, QC/validation, and team leadership
• Must have 15+ years of clinical SAS programming experience to provide technical leadership across complex clinical studies, particularly Phase III trials.

Working Condition

This position operates in an office setting, in person.

Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Direct Reports

N/A