Biostatistician (Sr./Principal)

Senior/Lead Biostatistician
Experience: 5–10+ years
Location: Hyderabad / India
Employment Type: Full-time / Contract
Role Overview:
We are looking for an experienced Senior/Lead Biostatistician with strong expertise in Bioavailability (BA), Bioequivalence (BE), Pharmacokinetics (PK), and clinical studies. The candidate should be capable of independently leading projects, managing client interactions, and serving as the primary statistical POC.
Key Responsibilities:
The role will involve end-to-end statistical support for BA/BE and PK studies, including parallel, crossover and replicate designs, treatment allocation, PK/kinetic evaluations, population bioequivalence, toxicokinetic and specialized in vitro studies. The candidate will also support clinical studies across Phase I–III, including study design, sample size estimation, treatment allocation, SAP development, statistical analysis, SAR preparation, and interpretation of study results.
The role requires experience with CDISC compliance, SEND, and Tables, Listings and Figures (TLFs), along with the ability to oversee statistical deliverables and coordinate with programming/data management teams.
Requirements:
5–10+ years of relevant Biostatistics experience with strong BA/BE expertise.
Strong knowledge of PK/BE statistical methodologies and clinical study designs.
Experience with SAPs, SARs, sample size estimation and TLF development.
Familiarity with CDISC standards and SEND.
Experience across Phase I–III clinical studies is preferred.
Strong client-facing, project leadership and communication skills.
Ability to independently lead projects and act as the primary client POC.
Experience with SAS and/or R is preferred.

Work arrangement
Hybrid