• Serve as the lead statistician for assigned individual clinical studies, providing hands-on support for study design, power and sample size calculations, statistical analysis plans, TFL shells, and interpretation of results • Execute and oversee statistical analyses, including review of tables, listings, and figures generated by internal teams or CROs • Prepare and review statistical methods and results sections for clinical study reports and contribute to integrated analyses • Provide statistical guidance on study design, data collection, data review, and analysis for clinical trials • Support efficient medical and safety data review and monitoring activities, including participation in DSMB meetings as needed • Contribute to the development and review of statistical components of regulatory submissions and responses to health authority questions • Support protocol development, amendments, and data review meetings with cross-functional teams • Review clinical study documentation for eCTD submissions, including familiarity with CDISC standards, SDTM, ADaM, and define.xml • Collaborate closely with clinical operations, data management, medical, regulatory, and safety teams to support global study execution • Contribute to continuous improvement of statistical processes