Biostatistics Director

Job Summary

Providing strategic statistical input, the full-time remote Biostatistics Director will oversee all statistical aspects of clinical development for oncology biosimilars, ensuring excellence in design, analysis, and reporting across multiple products and therapeutic areas.

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