Senior Director, Biostatistics

Generate Biomedicines•Somerville, MA

20h•$219,000 - $329,000

About The Position

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, demonstrat ing both strategic leade rship and hands-on ownership and ensur ing alignment across internal teams and external partners.

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 least one Respiratory Phase 3 clinical trials (asthma or COPD preferred).
Hands-on statistical leader cap able of independently serv ing as the statistical lead for a Phase 3 program, with full accountability for execution, and oversight of all internal and external (CRO) statistical work.
Led planning and execution of Phase 3 statistical activities and filing readiness, including DSMB support, interim analyses, ISS/ISE planning and delivery , and governance of statistical components of BLA/ sBLA submissions.
Direct involvement in regulatory interactions, with responsibility for review , approval and defense of statistical content used in agency submissions and responses.
Demonstrated e xperience applying clinical trial simulations or quantitative scenario analyses to inform study design , operating characteristics or decision-making.
Practical e xpertise in complex trial designs with understanding of real-world applications .
Proficiency in R and/or SAS.

Nice To Haves

Experience managing other statisticians as both technical lead and people manager.
Understanding of the full drug development lifecycle, from discovery through registration.
Experience working in dynamic, high- growth or lean biotech environments.
Experience with digital biomarkers or ML-informed study designs .
Familiarity with global regulatory requirements .
Involvement in industry forums or thought leadership initiatives .

Responsibilities

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 SAP s , statistical components of protocols, regulatory submissions, and support regulatory interactions with global health authorities.
Mentor and develop a high-impact biostatistics team, including coaching, mentor ing 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 team s and senior leadership.
Set and uphold clear expectation s for accountability , ownership, and professional conduct .
Develop and coach team members with an emphasis on evidence-based decision making, collaboration, and execution discipline .
Model professional , calm engagement during high- stakes, scientific, and regulatory discussions.
Encourage innovation within a framework of governance, transparency, and risk awareness .
Communicate transparently , clearly, and constructively with senior leadership and external stakeholders .