Senior Biostatistics Manager

Job Summary

A company is looking for a Senior Manager of Biostatistics.

Key Responsibilities

• Serve as the lead statistician for clinical studies, overseeing statistical design and authoring relevant documentation
• Lead the Integrated Summary of Safety and Efficacy strategy for regulatory submissions
• Collaborate with cross-functional teams to ensure statistical integrity and support regulatory submissions

Required Qualifications and Education

• Bachelor's degree in a related field required
• PhD or MS in statistics, biostatistics, or related fields
• Minimum of 3 years of experience for PhD candidates and 5 years for MS candidates
• Solid knowledge of statistical methodologies, particularly in oncology
• Good understanding of GCPs, ICH guidelines, and FDA regulations