Executive Director of Biostatistics

Job Summary

Leading the statistical function for clinical trials, the full-time remote Executive Director of Biostatistics will manage statistical design, ensure data integrity, and provide strategic guidance while overseeing departmental processes and staff development.

Key responsibilities

• Provide strategic direction and oversight for clinical trial design, data analysis, and reporting
• Build and maintain relationships with external partners, including regulatory agencies, to support best practices and regulatory strategy
• Manage and develop statistical staff through mentoring, performance management, and resource planning

Required qualifications

• PhD in Biostatistics or a related field, or an MS in Biostatistics
• 12+ years of relevant experience with a PhD, or 15+ years with a Master's degree, including 6 years of direct people management
• Demonstrated experience leading statistical strategy for NDAs, BLAs, and PMAs
• Deep expertise in adaptive clinical trial designs and advanced statistical methodologies
• Expert proficiency in SAS and familiarity with FDA and ICH regulatory frameworks