Senior Statistical Programmer

Description :

Role : Senior Statistical Programmer

Experience : 5 to 8 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 :

a. Clinical Study Reports (CSR)

b. Interim analyses

c. DSUR and DMC outputs

d. Investigator Brochure (IB) updates

e. 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.