Senior Director of Biostatistics

Job Summary

To support biosimilar development initiatives, the full-time remote Senior Director of Biostatistics will provide strategic statistical input, manage a team of biostatisticians, and oversee statistical aspects of product development while ensuring high-quality standards and regulatory compliance.

Key responsibilities

• Provide oversight for statistical protocols, analysis plans, and regulatory submissions
• Develop and maintain statistical excellence in design, analysis, and reporting throughout all phases of biosimilar development
• Lead and manage internal and CRO biostatistical teams to ensure timely completion of study deliverables

Required qualifications

• Doctorate degree with 5 years of experience, or Master's degree with 9 years, or Bachelor's degree with 11 years of relevant experience in biostatistics
• At least 5 years of direct management experience leading teams or projects
• Strong leadership skills with a proven track record in statistical strategy for regulatory submissions
• Experience in drug development processes, including pre-clinical and clinical development
• Knowledge of biosimilars development and global regulatory requirements