Director, Biostatistics

As the Lead Statistician, you will spearhead the statistical efforts of a clinical program, playing a key role in the clinical development plan, regulatory submissions, and overall data strategy. This role requires strategic involvement in program teams, authorship of statistical sections in study documents, and direct oversight of outsourced statistical functions. Act as the lead statistician of a clinical program, leading statistical efforts and representing biometrics functions on program teams. Make strategic contributions to the clinical development plan. Serve as the biostatistical lead for regulatory submissions and inspections, ensuring compliance with global regulatory standards. Contribute to the development of clinical protocols by authoring the statistical methods section and reviewing other sections for statistical accuracy. Develop and review statistical analysis plans. Provide statistical input during CRF design. Contribute to clinical study reports. Manage relationships with CROs.