Senior Director, Biostatistics

📋 Description

• Lead statistical strategy across clinical programs to align with development objectives and
• Provide statistical leadership for late-stage development, including pragmatic application of
• Draft and review SAPs, statistical components of protocols, regulatory submissions, and support
• Mentor and develop a high-impact biostatistics team, including coaching, mentoring and performance
• Collaborate with Biometrics leadership to establish, implement and enforce statistical standards
• Ensure high-quality, timely execution of statistical analyses in collaboration with

🎯 Requirements

• PhD in Statistics/Biostatistics with 12+ years in biotech/pharma, or MS with 15+ years.
• Prior biostatistics leadership experience in respiratory disease, with direct involvement in at
• Hands-on statistical leader capable of independently serving as the statistical lead for a Phase 3
• Led planning and execution of Phase 3 statistical activities and filing readiness, including DSMB
• Direct involvement in regulatory interactions, with responsibility for review, approval and defense
• Demonstrated experience applying clinical trial simulations or quantitative scenario analyses to

🎁 Benefits

• Annual bonus, equity compensation, and a competitive benefits package.