Senior Director, Biostatistics

Generate Biomedicines•Somerville, MA

About The Position

The Senior Director, Biostatistics is a statistical leader responsible for defining and executing statistical strategy for late-stage development programs and regulatory readiness. Reporting to the Head of Biometrics, this role partners closely with Clinical Development, Regulatory Affairs, Translational Medicine, and Clinical Pharmacology to support rigorous trial execution and informed decision-making from early development through registration. The Senior Director owns critical statistical deliverables, combining strategic leadership with hands-on execution and ensuring alignment across internal teams and external partners. The role leads statistical strategy across clinical programs, provides statistical leadership for late-stage development, and applies adaptive, Bayesian, or other innovative designs where appropriate. It includes drafting and reviewing statistical analysis plans, protocol statistical components, and regulatory submissions, as well as supporting interactions with global health authorities. The Senior Director ensures timely, high-quality analyses, applies advanced methodologies such as modeling and simulations, and communicates complex statistical concepts clearly to cross-functional teams and senior leadership. The position also develops a high-impact biostatistics team and collaborates with Biometrics leadership to establish and uphold statistical standards, processes, and best practices. Leadership expectations include setting clear expectations for accountability and professional conduct; coaching team members in evidence-based decision-making, collaboration, and execution; modeling calm engagement in high-stakes scientific and regulatory discussions; encouraging governed and transparent innovation; and communicating constructively with senior leaders and external stakeholders. Generate Biomedicines is a clinical-stage generative biology company using machine learning and large-scale experimentation to design proteins with defined biological intent and develop protein-based medicines. Founded in 2018, the company advances clinical and preclinical programs across multiple disease areas and protein modalities.

Requirements

PhD in Statistics or Biostatistics with 12 or more years of experience in biotech or pharma, or an MS with 15 or more years of experience.
Biostatistics leadership experience in respiratory disease, including direct involvement in at least one Phase 3 asthma clinical trial.
Ability to serve hands-on as the statistical lead for a Phase 3 program, with accountability for execution and oversight of internal and external (CRO) statistical work.
Experience leading 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 and responsibility for reviewing, approving, and defending statistical content in agency submissions and responses.
Experience applying clinical trial simulations or quantitative scenario analyses to inform study design, operating characteristics, or decision-making.
Practical expertise in complex trial designs and understanding of their real-world applications.
Proficiency in R and/or SAS.

Nice To Haves

Experience managing other statisticians as both a 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 machine-learning-informed study designs.
Familiarity with global regulatory requirements.
Involvement in industry forums or thought leadership initiatives.

Responsibilities

Lead statistical strategy across clinical programs in alignment with development objectives and regulatory expectations.
Provide statistical leadership for late-stage development, including pragmatic use of adaptive, Bayesian, or innovative trial designs where appropriate.
Draft and review statistical analysis plans, statistical components of protocols, and regulatory submissions.
Support regulatory interactions with global health authorities.
Mentor and develop the biostatistics team through coaching, mentoring, and performance feedback.
Collaborate with Biometrics leadership to establish, implement, and enforce statistical standards, processes, and best practices.
Ensure high-quality and 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, decision-oriented communications for cross-functional teams and senior leadership.
Set expectations for accountability, ownership, and professional conduct.
Promote evidence-based decision-making, collaboration, execution discipline, and innovation within a framework of governance, transparency, and risk awareness.
Oversee internal and external CRO statistical work and serve as statistical lead for a Phase 3 program.
Lead 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.
Review, approve, and defend statistical content used in agency submissions and responses.