Biostatistics Manager

Job Summary

To support the design and execution of clinical trials, the full-time Biostatistics Manager will oversee statistical analyses, collaborate cross-functionally, and ensure compliance with regulatory standards in a remote/hybrid work environment.

Key responsibilities

• Direct the development of statistical designs and analysis procedures for clinical protocols
• Collaborate with stakeholders to ensure data collection instruments meet project needs and develop data standards
• Prepare reports and represent statistical findings at project team meetings, ensuring scientific rigor and clarity

Required qualifications

• Ph.D. or M.S. in Biostatistics or Statistics
• At least 2+ years of industry experience for Ph.D. or 5+ years for M.S. in a pharmaceutical R&D environment
• Strong knowledge of statistical analysis principles and techniques, including software such as SAS and R
• Experience with NDA/BLA submissions and knowledge of dermatology or oncology drug development is a plus
• Demonstrated understanding of Phase I to Phase IV drug development