Generate Biomedicines

Director

• Lead statistical strategy across clinical programs to align with development objectives and regulatory expectations.
• Provide statistical leadership for late-stage development, including pragmatic application of adaptive, Bayesian, or innovative designs where appropriate.
• Draft and review SAPs, statistical components of protocols, regulatory submissions, and support regulatory interactions with global health authorities.
• Mentor and develop a high-impact biostatistics team, including coaching, mentoring and performance feedback.
• Collaborate with Biometrics leadership to establish, implement and enforce statistical standards, processes, and best practices.
• Ensure high-quality, timely execution of statistical analyses in collaboration with cross-functional teams.
• Apply advanced methodologies, including modeling and simulations to inform quantitative decision making while balancing feasibility, timelines, and scientific rigor.
• Translate complex statistical concepts into clear, aligned, and decision-oriented communication for cross-functional teams and senior leadership.

Senior Director, Biostatistics