Senior Director, Biostatistics

About the role

For our client, we are seeking a Senior Director, Biostatistics to join the team of a leader in the Pharmaceuticals & Biotech space. This leader will shape the statistical strategy behind biosimilar development programs across the full product lifecycle. The role will partner closely with clinical development, regulatory, and operational teams to ensure rigorous study design, high-quality analyses, and clear communication of statistical insights. In addition, this leader will guide a biostatistics organization and help strengthen processes that support efficient and compliant development execution.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Oversee statistical components in biosimilar development across all phases
• Maintain statistical excellence in study design and reporting for development
• Ensure consistency in clinical development strategies and analysis methods
• Provide statistical input for regulatory strategies and communications
• Guide internal staff and CROs to ensure timely completion of study goals
• Lead hiring, management, and development of the biostatistics team
• Develop and review SOPs to enhance operational efficiency in biosimilar research

Qualifications

• Doctorate in Statistics/Biostatistics plus 5 years of experience, Master's plus 9 years of experience, or Bachelor's plus 11 years of experience in a Senior Director role
• At least 5 years of direct people management experience
• Established record of strong leadership skills
• Experience with statistical leadership for regulatory submissions
• Demonstrated effective communication skills for statistical strategies

Benefits

• Opportunity to make a significant impact in the biosimilar field
• Influence strategic clinical development plans
• Work closely with regulatory authorities and industry leaders
• Lead a dedicated team of biostatisticians in a collaborative environment

Pay

Compensation: $223,625 – $302,551 annually