Generate Biomedicines

Senior Director, Biostatistics

Generate Biomedicines

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • United States

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Salary

💰 $219,000 - $329,000 per year

Job Level

Senior

About the role

  • 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.

Requirements

  • 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.
Benefits
  • annual bonus
  • equity compensation
  • competitive benefits package

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
statistical strategyadaptive designBayesian designstatistical analysismodelingsimulationsclinical trial simulationsquantitative scenario analysesbiostatisticsstatistical leadership
Soft skills
mentoringcoachingperformance feedbackcollaborationcommunicationdecision-oriented communicationleadershipteam developmentcross-functional teamworkorganizational skills
Certifications
PhD in StatisticsPhD in BiostatisticsMS in StatisticsMS in Biostatistics