Associate Director / Director, Biostatistics

The Associate Director / Director, Biostatistics will serve as the lead biostatistician for clinical programs or trials from Phase I through Phase III. Responsibilities include providing strategic input into clinical development plans, study designs, and statistical methodologies, and presenting statistical aspects to internal stakeholders. They will develop or review statistical sections of clinical trial protocols, SAPs, and other key documents. The role involves collaborating with internal teams and CROs to oversee statistical programming, analysis, and validation, and interpreting/communicating statistical results to clinical and regulatory stakeholders. Additionally, they will contribute to regulatory submissions, attend meetings with regulatory agencies, ensure statistical deliverables comply with regulatory requirements, identify process improvements, implement innovative statistical solutions, and represent Biostatistics in cross-functional project teams.