Biostatistics Manager

Job Summary

A company is looking for a Manager of Biostatistics to serve as a trial statistician for clinical studies.

Key Responsibilities

• Serve as trial statistician, supporting statistical design and authoring study protocols and Statistical Analysis Plans
• Collaborate with cross-functional teams to maintain statistical integrity and support regulatory submissions
• Develop data presentation plans and oversee statistical activities conducted by Contract Research Organizations

Required Qualifications

• PhD or MS in statistics or biostatistics related field required
• PhD with 0-3 years or MS with 3 years related experience or equivalent combination of education and experience
• Solid knowledge of statistical methodologies for oncology, including survival analysis and Bayesian Statistics
• Good understanding of GCPs, ICH guidelines, and FDA regulations is a plus
• Advanced proficiency in BASE SAS and R, or other statistical software is advantageous