Senior Director, Biostatistics

About Generate:Biomedicines

Generate:Biomedicines is a new kind of therapeutics company existing at the intersection of machine learning biological engineering and medicine pioneering Generative Biology to create breakthrough medicines where novel therapeutics are computationally generated instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions with an outsized opportunity for patients in need. We are seeking collaborative relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 millionin funding providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover Massachusetts with 300 employees.

The Role:

The Senior Director Biostatistics isa statisticalleader responsible for defining and executing statistical strategyforlate-stagedevelopmentprogram and regulatory readiness. ThisSenior 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 responsiblefor criticalstatisticaldeliverablesdemonstratingbothstrategic leadershipandhands-onownership and ensuringalignment across internal teams and external partners.

Heres how you will contribute:

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

• Providestatisticalleadership for late-stage development includingpragmatic application ofadaptive Bayesianor innovative designswhereappropriate.

• Draft and reviewSAPsstatistical components ofprotocolsregulatorysubmissionsandsupport regulatory interactionswith global health authorities.

• Mentorand develop a high-impact biostatistics team includingcoachingmentoringand performancefeedback.

• Collaborate with Biometrics leadership toestablish implementandenforcestatistical standards processes and best practices.

• Ensure high-qualitytimelyexecution of statistical analyses in collaboration with cross-functional teams.

• Applyadvanced methodologies including modeling and simulationsto inform quantitative decision making while balancing feasibility timelinesand scientificrigor.

• Translate complex statistical concepts into clear aligned and decision-orientedcommunication forcross-functionalteamsandsenior leadership.

Leadership Responsibilities

• Setandupholdclear expectationsforaccountabilityownershipandprofessional conduct.

• Develop and coach team memberswith an emphasis on evidence-based decision making collaboration and execution discipline.

• Model professional calmengagement during high-stakesscientificand regulatory discussions.

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

• Communicate transparentlyclearlyand 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 one Respiratory Phase 3 clinical trials (asthma or COPD preferred).

• Hands-on statistical leadercapableofindependently servingas 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/sBLAsubmissions.

• Direct involvement in regulatory interactions with responsibility for reviewapprovaland defenseof statistical content used in agency submissions and responses.
• Demonstrated experienceapplyingclinical trial simulations or quantitative scenario analyses to informstudydesign operatingcharacteristicsor decision-making.
• Practicalexpertisein complex trial designswith understanding of real-world applications.
• Proficiencyin R and/or SAS.

Preferred

• Experience managing otherstatisticians as bothtechnical lead and people manager.

• Understanding ofthe 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.

Who Will Love This Job:

AtGenerate:Biomedicinesyoullhelp pioneer a revolutionary approach to drug development. Join a passionate mission-driventeamharnessing the power of generative biology to transform patients lives. As we scale your leadership will shape how we grow build and deliver on our vision.

Generate:Biomedicines is committed 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 Companys 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.

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