Job Title

Senior Statistical ProgrammerExperience: 5–8 YearsLocation: HyderabadRole OverviewThe 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 ResponsibilitiesDevelop 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 analysesDSUR and DMC outputsInvestigator Brochure (IB) updatesExploratory analyses and publicationsCreate 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 SkillsStrong 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.