Director of Biostatistics

Job Summary

Providing strategic oversight and collaboration, the full-time Director of Biostatistics will manage study design, analyses, and regulatory submissions while ensuring high-quality deliverables in a remote work environment.

Key Responsibilities

• Provide strategic input to optimize trial designs for early and late phase studies
• Collaborate with clinical trial teams to support study conduct and ensure timely deliverables from external CROs
• Serve as the statistical lead for regulatory interactions, including thorough reviews of clinical documents and submissions

Required Qualifications

• Ph.D. or M.S. in Biostatistics or equivalent with at least 5 years of relevant experience
• Profound understanding of advanced clinical trial design and statistical analysis methodologies
• Strong leadership skills with the ability to work in cross-functional teams
• Good statistical programming skills using SAS and other statistical software
• Knowledge of regulatory requirements and good clinical practice guidelines