Senior Director, Biostatistics

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'll 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 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.

The Ideal Candidate will have:

• 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 asthma Phase 3 clinical trials.

• Hands-on statistical leader capable of independently serving 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 experience applying clinical trial simulations or quantitative scenario analyses to inform study design, operating characteristics or decision-making.
• Practical expertise in complex trial designs with understanding of real-world applications.
• Proficiency in R and/or SAS.

Preferred

• 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.

Nice to Have (Optional)

• Experience with digital biomarkers or ML-informed study designs.

• Familiarity with global regulatory requirements.

• Involvement in industry forums or thought leadership initiatives.

*Note: All applicants will be considered, however, a preferred candidate has been identified.

About Generate Biomedicines

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.

Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.

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