Sr Biostatistician (Therapeutic Areas -Oncology / Vaccines)

Sr Biostatistician responsibilities include providing support across all assigned statistical tasks from protocol to CSR, preparing Statistical Analysis Plans (SAPs) with mock-up displays for tables/listings/figures, and collaborating with sponsors when required. May be responsible for the statistical aspects of the protocol, randomization schedule, publications, and input to the clinical study report. Coordinates activities of other biostatistics and programming personnel to ensure timely, high-quality work; provides independent review of colleagues’ work. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures; reviews SAS annotated CRFs, database design, and other study documentation to ensure protocol criteria are met and data are captured to support high-quality analyses. Conducts verification and quality control of deliverables, implements company objectives, and serves as biostatistics representative on project teams, interfacing with other stakeholders. Manages scheduling and time constraints across multiple projects, sets goals based on management priorities, and communicates difficulties to management. Monitors progress against milestones and ensures adherence to timelines. Experience required: senior biostatistician (5–8 years) with experience in SAP writing, mock shell creations, randomization, CSR review, estimand framework, Bayesian methods (nice to have), and experience with RWE-EHR, claims, and registries. CDISC and SAS experience with lead statistician experience desired. Oncology is a preferred therapeutic area. The role emphasizes collaboration across global teams, flexibility, and delivering impactful statistical solutions in drug development. Locations noted as IND-Remote, India.