Vice President, Biometrics and Clinical Analytics

Aditum Bio; Oakland (MA); On-site; USD 330,000 - 365,000; Full time

Job summary

Aditum Bio in the United States is seeking a senior leader to head biometrics and clinical analytics, guiding biostatistics, programming, data management, and reporting across early-stage studies. The role partners with clinical development, regulatory, quality, and executives to design rigorous, cost-efficient studies and deliver near real-time visibility into data.

This high-impact, portfolio-level position may act as study statistician or oversee CROs and consultants, while staying hands-on

Qualifications

• PhD or MS in Biostatistics or related quantitative discipline.
• 12+ years in biometrics (biotech/pharma), with ≥5 years leading strategy.
• Proficiency in statistical programming (R/SAS) and independent analyses.
• Hands-on data visualization experience (Spotfire/Tableau/Power BI/R Shiny).
• Experience supporting early-stage health authority interactions and DSURs.

Responsibilities

• Strategic biometrics leadership and trial design across programs.
• Organizational leadership, team building, and vendor framework Scaling.
• Sourcing and vendor strategy across CROs and consultants.
• Oversee data management systems, safety data, and QCs with CDISC standards.
• Analytics, reporting, and statistical programming for real-time insights.
• Cross-functional collaboration with clinical, regulatory, and business teams.

Skills

Biometrics leadership

Statistical programming

Data visualization

Trial design

Vendor management

Education

Biostatistics PhD/MS

Tools

Spotfire

Tableau

Power BI

R

SAS

Job description

CompanyOverview

At Aditum Bio, our mission is to rapidly translate scientific discoveries into new medicines. Co-founded by industry veterans Joe Jimenez, former CEO of Novartis and Mark Fishman, former President of the Novartis Institutes for Biomedical Research, the firm in-licenses promising therapies that for some reason are not advancing toward the clinic. The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual market launch, to reach patients in need.

Position Summary

The VP of Biometrics and Clinical Analytics will provide hands-on leadership across the biometrics function—biostatistics, statistical and clinical programming, data management, clinical analytics, safety, and systems—supporting first-in-human, dose-escalation, proof-of-concept, and biomarker-driven studies. The role partners with clinical development, operations, translational science, regulatory, quality, and executive leadership to design rigorous, capital-efficient studies and deliver near-real-time visibility into clinical and operational data

Thishigh-impact,portfolio-levelrolesuitsaseniorbiometricsandanalyticsleaderwhothrivesinearly-stageenvironments,shapesprogramsatcriticalinflectionpoints,andownsthebiometricssourcingstrategyacrossCROs,consultants,andvendors.ThispersonmayserveasstudystatisticianoroverseeconsultantsandfutureFTEs,whileremainingahands-onresourceforcoreanalysesacrossteams.

PositionResponsibilities

• StrategicBiometricsLeadership&TrialDesign.Serveastheseniorbiometricsleadacrossprograms,shapingdevelopmentstrategy,trialdesign,endpointselection,andriskmitigation.ContributetoPhaseI/IIdesign(adaptive,Bayesian,dose-finding,andnovelendpoints);developandreviewstatisticalsectionsofprotocols,SAPs,andCSR/regulatorydocuments;andsupporthealthauthorityinteractions,SRC/DMC/DSMBactivities,interimanalyses,andindependentstatistical/unblindingprocesses—ensuringqualityandconsistencyofbiometricsapproacheswiththeCMO.
• OrganizationalLeadership&TeamBuilding.Serveasaseniorindividualcontributorwhodeliverscorebiometricsworkwhileestablishingthestandards,processes,andvendorframeworkthatscalethefunction.Astheportfoliogrows,build,hire,andmentoraninternalbiometricsteamoverthelongterm.
• Sourcing&VendorStrategy.DefineandimplementAditum’sbiometricssourcingmodel—scoping,selecting,contracting,andoverseeingCROs,functionalserviceproviders,consultants,andspecialtyvendors—buildingrelationshipsthatprovidesurgecapacityandspecializedcapabilitieswhilemaintainingcapital-efficientresourcing.
• DataManagement,Systems&Quality.Overseeclinicaldatamanagement,safetydata,andthesystemsecosystem(EDC,safetydatabase,datacapture,andanalytics/reportingplatforms),andsupportexpedited(E2B)andaggregatesafetyreporting(e.g.,DSURs)withpharmacovigilance.MaintainbiometricsSOPsanddatastandards(CDISC/SDTM/ADaM),ensuringdataqualityandintegrity,GCP/ICH(E6,E9)compliance,andauditandinspectionreadinessacrossinternalandvendoractivities.
• Analytics,Reporting&StatisticalProgramming.Buildnear-real-timevisualizationsandoperationaldashboardsfromCRO-sourceddatatostrengthenstudyoversight,andindependentlygenerateanalysesandmaintainanalysisdatasetsforadhocinternalreporting.Overseethequalityofvendorprogrammingoutputsandchampionreproducible,well-documentedpractices.
• CrossFunctional&ExternalPartnerCollaboration.PartnerwithClinical,Regulatory,Medical,Translational,CMC,andBusinessDevelopmentteams,andoverseeCROsandvendorsacrossbiometricsactivities.Communicatecomplexstatisticalconceptsclearlytonon-statisticianstakeholders,adaptingdepthandlanguagetotheaudience.

Qualifications

• PhDorMSinBiostatistics,Statistics,orrelatedquantitativediscipline.
• 12+yearsinbiometrics(biotech/pharma),including5+yearsleadingstatisticalstrategyandmoderntrialmethodologiesforPhaseI/IIprograms—directlyasstudystatisticianoroverseeingoutsourcedbiostatistics—withhands-onexperienceonearly-stage(first-in-humantoproof-of-concept)programsandsuccessinleanorstartupenvironments.
• Demonstratedproficiencyinstatisticalprogramming(Rand/orSAS),withtheabilitytoindependentlygenerateanalyses,reviewanalysisdatasetsandoutputs,andsupportrapiddata-drivendecisions.
• Hands-onexperiencebuildinginteractivedatavisualizationsandoperationaldashboards(e.g.,Spotfire,Tableau,PowerBI,RShiny)deliveringnear-real-timeinsighttoclinicalandoperationalteams.
• Experiencesupportingearly-stagehealthauthorityinteractions,includingpre-INDandTypeB/C/DmeetingsandFDA/NCA/EMAscientificadvice.
• Experienceoverseeingclinicaldatamanagementandsystems(EDC,CDISCstandards,analytics/reportingplatforms)andaggregatesafetyreporting(e.g.,DSURs),withtheabilitytotranslateCRO/EDCdataflowsintodecision-readyreporting.
• ExperiencewithDataMonitoringCommittees(SRC/DMC/DSMB),independentstatistics/unblinding,andbiometricsqualitypractices(GCP/ICHE6andE9,SOPs,andinspectionreadiness).
• Experiencemanagingfunctionalbudgetsandresourceplanningacrossinternalandoutsourced(CRO/FSP)capacity.
• Exceptionalcommunicatorwhotranslatescomplexstatisticalandanalyticalconceptsfornon-technicalaudiencesandpresentsconfidentlyatgovernanceandinvestmentforums.

The range for this full-time position is $330,000 - 365,000 plus a target bonus, equity compensation and benefits including medical, dental, vision, and 401k. Our salary ranges are determined by role, level and location. The range displayed on our postings reflects the minimum and maximum for new hire salaries. Within the range, individual pay is determined by interview performance, job-related skills, experience and relevant education and training. Please note the range reflects base salary and does not include target bonus, equity or benefits.

We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.