Senior Director, Biostatistics

Generate Biomedicines•Somerville, MA

3d•$219,000 - $300,000

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 alignment across internal teams and external partners. The role leads statistical strategy across clinical programs, oversees statistical activities and filing readiness for Phase 3 programs, supports regulatory interactions, and develops a high-impact biostatistics team. The position also contributes to standards, processes, and best practices across Biometrics and communicates statistical concepts clearly to cross-functional teams, senior leadership, and external stakeholders. Generate:Biomedicines is a clinical-stage generative biology company using machine learning and large-scale experimentation to design proteins and develop protein-based medicines. Founded in 2018, the company advances clinical and preclinical programs across disease areas and protein modalities.

Requirements

PhD in Statistics or Biostatistics with 12 or more years of biotech/pharma experience, or 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.
Hands-on statistical leadership capability, including the ability to independently lead a Phase 3 program and oversee internal and CRO statistical work.
Experience leading Phase 3 statistical planning and execution and filing readiness, including DSMB support, interim analyses, ISS/ISE planning and delivery, and 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.
Demonstrated experience using 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 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 ML-informed study designs.
Familiarity with global regulatory requirements.
Involvement in industry forums or thought leadership initiatives.

Responsibilities

Lead statistical strategy across clinical programs, aligning it with development objectives and regulatory expectations.
Provide statistical leadership for late-stage development, including pragmatic application of adaptive, Bayesian, or other innovative designs where appropriate.
Draft and review statistical analysis plans, statistical components of protocols, and regulatory submissions; support 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, 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 communication for cross-functional teams and senior leadership.
Set and uphold expectations for accountability, ownership, and professional conduct.
Develop and coach team members, emphasizing 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.
Independently serve as statistical lead for a Phase 3 program, with accountability for execution and oversight of internal and CRO statistical work.
Lead 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.
Review, approve, and defend statistical content used in agency submissions and responses.