Vice President, Biometrics and Clinical Analytics

Vice President, Biometrics and Clinical Analytics

Hybrid from Oakland, California or Cambridge, Massachusetts

Company Overview

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,and vendors.

ThispersonmayserveasstudystatisticianoroverseeconsultantsandfutureFTEs,whileremainingahands‑onresourceforcoreanalysesacrossteams.

Position Responsibilities

• Strategic Biometrics Leadership &Trial Design. Serve as this senior biometrics lead across programs, shaping development strategy, trial design, endpoint selection, and risk mitigation. Contribute to Phase I/IIdesign(adaptive,Bayesian,dose‑finding,and novel endpoints); develop and review statistical sections of protocols, SAPs, and CSR/regulatory documents; and support health authority interactions, SRC/DMC/DSMB activities, interim analyses, and independent statistical/unblinding processes—ensuring quality and consistency of biometrics approaches with the CMO.
• Organizational Leadership&Team Building. Serve as a senior individual contributor who delivers core biometrics work while establishing the standards, processes, and vendor framework that scale the function. As the portfolio grows, build, hire, and mentor internal biometric teams over the long term.
• Sourcing&Vendor Strategy
  . Define and implement Aditum’s biometric sourcing model—scoping, selecting, contracting, and overseeing CROs, functional service providers, consultants, and specialty vendors—building relationships that provide surge capacity and specialized capabilities while maintaining capital‑efficient resourcing.
• Data Management,Systems&Quality. Oversee clinical data management, safety data, and the systems ecosystem (EDC, safety database, data capture, and analytics/reporting platforms), and support expedited(E2B) and aggregate safety reporting (e.g.,DSURs) with pharmacovigilance. Maintain biometrics SOPs and data standards (CDISC/SDTM/ADaM), ensuring data quality and integrity, GCP/ICH(E6,E9) compliance, and audit and inspection readiness across internal and vendor activities.
• Analytics,Reporting&Statistical Programming. Build near‑real‑time visualizations and operational dashboards from CRO‑sourced data to strengthen study oversight, and independently generate analyses and maintain analysis datasets for ad hoc internal reporting. Oversee the quality of vendor programming outputs and champion reproducible, well‑documented practices.
• Cross Functional&External Partner Collaboration . Partner with Clinical, Regulatory, Medical, Translational, CMC, and Business Development teams, and oversee CROs and vendors across biometrics activities. Communicate complex statistical concepts clearly to non‑statistician stakeholders, adapting depth and language to the audience.

Qualifications

• PhD or MS in Biostatistics, Statistics, or related quantitative discipline.
• 12+ years in biometrics (biotech/pharma), including 5+ years leading statistical strategy and modern trial methodologies for…