Generate:Biomedicines · 2 days ago
Senior Director, Biostatistics
United States
Full-time
Remote
Director/Executive
$219K/yr - $329K/yr
12+ years expGenerate:Biomedicines is a therapeutics company that leverages machine learning and biological engineering to pioneer Generative Biology™ for drug development. The Senior Director, Biostatistics will lead statistical strategy for late-stage development programs, ensuring rigorous trial execution and collaboration across various departments.
Artificial Intelligence (AI)BiotechnologyHealth CareMedicalProduct Research
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 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
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
Qualification
Required
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 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
Experience with digital biomarkers or ML-informed study designs
Familiarity with global regulatory requirements
Involvement in industry forums or thought leadership initiatives
Benefits
Annual bonus
Equity compensation
Competitive benefits package
Company
Generate:Biomedicines
Pioneering generative biology to create breakthrough therapeutics.
201-500 employees
H1B Sponsorship
Generate:Biomedicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (12)
2023 (9)
2022 (3)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$693MKey Investors
Samsung Life Science FundAlumni VenturesFlagship Pioneering
2024-12-18Series Unknown
2023-09-14Series C· $273M
2021-11-18Series B· $370M
Leadership Team
Gevorg Grigoryan
Founding CTO
Recent News
FierceBiotech
2025-10-28
Company data provided by crunchbase