Senior Director, Biostatistics

About Generate:Biomedicines

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role: 

The Senior Director, Biostatistics is a statistical leader responsible for defining and executing statistical strategy for late-stage development program, and regulatory readiness. This Senior Director, Biostatistics will report to Head of Biometrics and expected to partner closely with Clinical Development, Regulatory Affairs, Translational Medicine, and Clinical Pharmacology to ensure scientific rigorous trial execution, and informed decision-making from early development through registration.  

The Senior Director will be directly responsible for critical statistical deliverables, demonstrating both strategic leadership and hands-on ownership and ensuring alignment across internal teams and external partners.  

Here's how you will contribute:

• 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. 

Leadership Responsibilities 

• Set and uphold clear expectations for