TCS is hiring for Senior Biostatistician
Job Location – Mumbai, Pune, Bangalore, Hyderabad, Chennai
Experience Range – 3 to 10 Years
Educational qualification:
- Ph.D. in Statistics, Biostatistics, or a closely related field, or
- Master’s degree in Statistics, Biostatistics, or a related quantitative discipline with substantial experience in clinical research
Responsibilities:
Role: Senior Biostatistician – Pharma Studies
Experience
- 6+ years’ biostatistics experience within global pharma clinical development (sponsor and/or CRO), with accountability for end-to-end statistical strategy and deliverables.
- Provide statistical leadership across Phase I–IV trials, delivering protocol inputs on study design, endpoints, estimands (ICH E9(R1)), randomization/blinding, interim analyses, and missing-data strategy; contribute to CRF/EDC design to ensure analyzable data capture.
- Author/review Statistical Analysis Plans and associated shells/specifications with inspection-ready traceability; ensure alignment with global regulatory expectations (FDA, EMA, PMDA) and internal standards.
- Conduct sample size and power estimation (including simulation where appropriate); document assumptions, operating characteristics, and sensitivity analyses.
- Strong applied methodology across core clinical trial analyses: time-to-event, longitudinal/repeated measures, mixed models, multiplicity control, subgroup/sensitivity analyses, and benefit–risk/diagnostic performance as applicable.
- Experience with advanced/innovative designs and methods (adaptive, Bayesian, platform/master protocols, dose-finding, simulation)
- Contribute to clinical study reports (CSR), integrated summaries (ISS/ISE), briefing documents, and responses to regulatory questions; support publications with statistically sound interpretation.
- Provide oversight/mentoring to statisticians and programming partners; drive quality, timeliness, and compliance with SOPs, GCP (ICH E6), and data standards (CDISC SDTM/ADaM) in a global delivery model.
- Collaborate with cross-functional teams (Clinical Development, Data Management, Programming, Medical Writing, Safety, Regulatory, HEOR) and represent Statistics in global governance and strategic forums.
- Strong familiarity with global regulatory guidance impacting statistical work (ICH E9/E9(R1), ICH E3, ICH E6, FDA/EMA/PMDA guidance) and inspection readiness expectations
Technical Skills:
- Proficiency in SAS (mandatory).
- Working knowledge of R is preferred.
- Good understanding of CDISC concepts (SDTM/ADaM) and their impact on statistical analysis.
