Director of Biostatistics

Job Summary

A company is looking for a Director of Biostatistics to lead statistical strategy in clinical trials for autoimmune and inflammatory diseases.

Key Responsibilities

• Apply advanced statistical methods to clinical trial data and support regulatory submissions
• Provide statistical input for drug development plans and clinical study designs
• Manage CROs and ensure the quality and accuracy of study data and statistical outputs

Required Qualifications

• Ph.D. in Biostatistics with at least 8 years of experience, or a Master's with a minimum of 10 years of relevant experience
• Strong expertise in statistical experimental design and clinical trial analysis
• Proven track record with Integrated Summaries of Safety and Effectiveness for regulatory submissions
• Recent NDA submission experience required
• Proficiency with R and SAS software; immunology experience preferred