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

• Develop and oversee statistical analysis plans for Phase 2 and 3 clinical trials
• Provide statistical input for drug development plans and clinical study designs
• Manage CRO partners and ensure the quality and accuracy of statistical outputs

Required Qualifications

• Ph.D. in Biostatistics with 8+ years of experience, or Master's with 10+ years of relevant experience
• Strong expertise in statistical experimental design and regulatory requirements
• Recent NDA submission experience is required
• Proficiency in R and SAS software
• Immunology experience is preferred