Director of Biostatistics In this role, reporting to the Vice President of Biometrics, you will work with cross-functional clinical teams overseeing statistical activities across clinical programs, including managing statistical deliverables outsourced to CROs. This is an exciting opportunity to contribute to the development of transformative therapies. Responsibilities: • Serve as a biostatistics expert for clinical programs. • Provide strategic input for trial designs in early-phase and late-phase studies. • Collaborate with internal and CRO team members to coordinate statistical deliverables. • Conduct statistical modeling for efficient study designs and address statistical issues. • Contribute to protocol development and author statistical analysis plans. • Review eCRF designs to ensure data collection meets analysis requirements. • Oversee QC/QA of statistical deliverables and perform ad hoc analyses as needed. • Support IND/NDA/MAA regulatory submissions and address queries from regulatory agencies. • Contribute to publications, including manuscripts and presentations. • Lead standardization and process improvement efforts for the Biostatistics function. Requirements: • PhD in Statistics or related field, or MS with relevant experience. • 8+ years in the pharmaceutical or biotech industry. • Experience in clinical trial design, analysis, and reporting. • Proficient in statistical programming (SAS and R). • Familiarity with FDA, EMA, and ICH regulations. • Strong communication and collaborative skills.