Senior Director, Biostatistics

The Role: 

The Senior Director, Biostatistics isa statisticalleader responsible for defining and executing statistical strategyfor late-stagedevelopment program, and regulatory readiness.This Senior Director, Biostatistics will report to Head of Biometrics andexpected topartner closely with Clinical Development, Regulatory Affairs, Translational Medicine, and Clinical Pharmacology to ensure scientificrigoroustrial execution,and informed decision-making from early development through registration.  

The Senior Director willbedirectly responsible for criticalstatisticaldeliverables,demonstrating both strategic leadershipandhands-onownership and ensuring alignment across internal teams and external partners.  

Here's how you'll contribute: 

• Lead statistical strategy across clinical programs to align with developmentobjectives and regulatory expectations. 

• Providestatisticalleadership for late-stage development, includingpragmatic application ofadaptive, Bayesian,or innovative designswhereappropriate. 

• Draft and reviewSAPs,statistical components ofprotocols,regulatorysubmissions, andsupport regulatory interactionswith global health authorities. 

• Mentor and develop a high-impact biostatistics team, includingcoaching,mentoring and performancefeedback. 

• Collaborate with Biometrics leadership toestablish,implementandenforce statistical standards, processes, and best practices. 

• Ensure high-quality,timely execution of statistical analyses in collaboration with cross-functional teams. 

• Applyadvanced 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-functionalteams andsenior leadership. 

Leadership Responsibilities 

• Setandupholdclear expectations for accountability,ownership, andprofessional 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. 

• Encourageinnovation within a framework of governance, transparency, and risk awareness. 

• Communicate transparently,clearly,and constructivelywith 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 inat least oneasthma Phase 3 clinical trials. 

• Hands-on statistical leadercapableofindependently serving as the statistical lead for a Phase 3 program, with full accountability for execution, and oversight of allinternal and external (CRO)statistical work. 

• Led planning and execution of Phase 3 statistical activities and filing readiness, including DSMB support, interim analyses, ISS/ISEplanning and delivery, and governance of statistical components of BLA/sBLA submissions. 
• Direct involvement in regulatory interactions, with responsibility for review,approvaland defenseof statistical content used in agency submissions and responses. 
• Demonstrated experienceapplyingclinical trial simulations or quantitative scenario analyses to informstudydesign, operatingcharacteristics or decision-making. 
• Practicalexpertise in complex trial designs with understanding of real-world applications.
• Proficiency in R and/or SAS. 

Preferred 

• Experience managing otherstatisticians as bothtechnical lead and people manager. 

• Understanding of the full drug development lifecycle, from discoverythroughregistration. 

• Experienceworkingin dynamic, high-growthor lean biotechenvironments. 

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.

At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.

Generate:Biomedicines iscommitted to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.