Senior Statistical Programmer

About the role

The Senior Statistical Programmer is responsible for programming, validating, and delivering statistical datasets and outputs to support clinical trial analysis and regulatory submissions. Working closely with Biostatistics, Data Management, and Clinical teams, this role contributes to the delivery of high-quality, CDISC-compliant datasets and analysis results for Phase I–IV clinical trials.

What you'll do

• Programming & Validation Develop, test, and validate SDTM and ADaM datasets according to CDISC standards
• Program Tables, Listings, and Figures (TLFs) in support of clinical study reports (CSRs) and regulatory submissions
• Translate statistical analysis plans (SAPs) into accurate and efficient code
• Project Support Serve as the lead programmer on individual studies or studies within a program
• Collaborate with cross functional teams including Biostatisticians, Clinical Data Managers, and Regulatory personnel

What you need

• 4–6 yrs of experience
• Regulatory affairs
• SAS
• CRO
• Documentation
• SOP writing
• GCP
• B.Tech or B.E. or B.Sc or BCA or M.Tech or MCA or M.Sc

Good to have

• SQL
• R
• Python
• VBA
• Clinical research