Senior Manager, Biostatistics
Core
Lead biostatistics activities for clinical studies and non-molecule projects, including statistical analysis, trial design consultation, and regulatory submissions.
Role type
Senior Manager, Biostatistics
Builds
Statistical analysis plans, regulatory documentation (NDA), and clinical development data for biopharma products.
Domain
Biopharmaceuticals / Clinical Development
Required skills
Biostatistics, SAS programming, Clinical trial design, Statistical analysis, Project management, Team leadership, Regulatory compliance, Data management, Software development, Cross-functional collaboration
Preferred skills
PhD in biostatistics, Experience leading small projects and teams, Experience with biomedical data analysis
Technologies
SAS
Responsibilities
Lead statistical analysis and document review for NDA submissions; Provide statistical consultation on trial design and endpoints; Oversee technical and operational statistical activities for clinical trials; Direct internal and external teams on statistical activities; Participate in cross-functional clinical development and protocol design; Develop and maintain complex statistical databases; Advise on statistical analysis strategies and interpretation of results.
Seniority
Senior Manager, hands-on IC with team leadership