Director of Biostatistics

Job Summary

Leading a biostatistics team, the full-time remote Director of Biostatistics will develop strategic plans, provide statistical leadership for clinical programs, and ensure compliance with regulatory standards while overseeing data analysis and reporting for clinical studies.

Key responsibilities

• Manages in-house and contract biostatisticians for data analysis and reporting in clinical development programs
• Provides statistical leadership and strategic input to the Development Core Team regarding drug development and commercialization
• Collaborates with cross-functional teams to develop clinical study protocols, statistical analysis plans, and clinical study reports

Required qualifications

• Master's degree in statistics, biostatistics, or related discipline with 10+ years of relevant experience, or PhD with 7+ years of experience
• Extensive leadership experience in the pharmaceutical industry, particularly in clinical study design, analysis, and reporting
• Advanced knowledge of SAS programming and experience with CDISC and FDA standards
• Demonstrated experience in providing statistical leadership for drug development plans and commercialization activities
• Strong negotiation, influencing, and organizational skills with the ability to lead multiple projects to successful completion