Statistical Programmer

TCS is hiring for Statistical Programmer role. Job Location Mumbai - Pune | Bangalore | Hyderabad | Chennai | Indore | Kolkata | Noida. Senior Statistical Programmer: 5+ years of hands-on statistical programming experience. Lead Statistical Programmer: 8+ years of hands-on statistical programming experience. Strong exposure across Phase I–IV clinical trials. Therapeutic expertise in Oncology, Immunology, and Neuroscience. Technical Expertise: SAS Programming (Base SAS, Macros, SQL), SDTM, ADaM & TLFs, CDISC Standards, Dataset and TLF development, validation, and maintenance, Pinnacle21, Define.xml, Reviewer’s Guides, FDA / PMDA / EMA regulatory submissions, Onshore–offshore collaboration and client communication. Roles & Responsibilities: Leads the statistical programming activities for a compound/indication. Leads a team of statistical programmers and manages the resource planning for assigned staff. Ensures timely deliverables, that all quality processes are followed and consistency within the projects. Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards. Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures. Ensures consistency of ADaM data sets for individual studies and integrated data.