Log In
Sign Up
Senior Statistical Programmer
Experience: 6–12 Years
Location: Hyderabad
Role Overview
The Senior Statistical Programmer will support clinical trial programming activities including SDTM, ADaM dataset development and TLF programming in compliance with CDISC standards . The role requires hands-on programming and collaboration with Biostatistics to deliver high-quality outputs for clinical study reporting.
Key Responsibilities
- Develop and validate SDTM and ADaM datasets in accordance with CDISC standards.
- Program and validate Tables, Listings, and Figures (TLFs) to support:
- Clinical Study Reports (CSR)
- Interim analyses
- DSUR and DMC outputs
- Investigator Brochure (IB) updates
- Exploratory analyses and publications
- Create SDTM CRF annotations and support development of SDTM dataset specifications .
- Contribute to ADaM dataset development aligned with Protocol, SAP, and mock shells.
- Support define.xml creation and validation .
- Provide programming support to Biostatistics teams for statistical analysis.
- Review study-related documentation including Protocol, SAP, mock shells, and data transfer specifications .
- Participate in safety reporting and regulatory documentation support .
Technical Skills
- Strong hands-on experience in SAS programming and Macro development .
- Experience in end-to-end programming including SDTM, ADaM, and TLF generation .
- Experience with BIMO submissions and ISS/ISE pooling preferred.
- Knowledge of Oncology therapeutic area is desirable.
- Exposure to HTA analyses preferred.
- Working knowledge of R programming is a plus.
- Good understanding of ICH guidelines and CDISC standards .
