Senior Biostatistician

TCS Hiring for Senior Biostatistician – Pharma StudiesExperience - 6-12yrsEducational qualification: Ph.D. in Statistics, Biostatistics, or a closely related field, orMaster’s degree in Statistics, Biostatistics, or a related quantitative discipline with substantial experience in clinical researchExperience6+ 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 expectationsTechnical Skills:Proficiency in SAS (mandatory).Working knowledge of R is preferred.Good understanding of CDISC concepts (SDTM/ADaM) and their impact on statistical analysis.RegardsManisha Singh (TCS HR)

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