Biostatistics Director

Key Responsibilities: Develop and maintain statistical excellence in design, analysis, and reporting for biosimilar development Review and contribute to clinical development plans, regulatory documents, and statistical analysis plans Manage and develop internal statistical staff while ensuring adherence to technical quality and standards in clinical development strategy

Required Qualifications: Doctorate degree and 4 years, Master's degree and 8 years, or Bachelor's degree and 10 years of Biostatistics experience Deep knowledge of statistical methodology and applications in drug development, especially in oncology Experience in statistical methodologies related to adaptive designs Demonstrated leadership in statistical strategy for regulatory submissions Life cycle drug development experience, including pre-clinical and clinical development