Aditum Bio

Aditum Bio

Vice President, Biometrics and Clinical Analytics

Hybrid from Oakland, CA or Cambridge, MA · Exec

Sponsorship not specifiedDetected 15 hours ago
GCPData VisualizationStatisticsBusiness DevelopmentFDA RegulatorySASResearchLeadershipBiostatistics

About the role

  • This person may serve as study statistician or oversee consultants and future FTEs, while remaining a hands-on resource for core analyses across teams.

Responsibilities

  • Strategic Biometrics Leadership & Trial Design.
  • Serve as the senior biometrics lead across programs, shaping development strategy, trial design, endpoint selection, and risk mitigation.
  • Contribute to Phase I/II design (adaptive, Bayesian, dose-finding, and novel endpoints)
  • develop and review statistical sections of protocols, SAPs, and CSR/regulatory documents
  • 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 an internal biometrics team over the long term.
  • Define and implement Aditum's biometrics 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.
  • 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.

Requirements

  • Demonstrated proficiency in statistical programming (R and/or SAS), with the ability to independently generate analyses, review analysis datasets and outputs, and support rapid data-driven decisions.
  • Experience with Data Monitoring Committees (SRC/DMC/DSMB), independent statistics/unblinding, and biometrics quality practices (GCP/ICH E6 and E9, SOPs, and inspection readiness).
  • Experience managing functional budgets and resource planning across internal and outsourced (CRO/FSP) capacity.
  • 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 Phase I/II programs-directly as study statistician or overseeing outsourced biostatistics-with hands-on experience on early-stage (first-in-human to proof-of-concept) programs and success in lean or startup environments.
  • Hands-on experience building interactive data visualizations and operational dashboards (e.g., Spotfire, Tableau, Power BI, R Shiny) delivering near-real-time insight to clinical and operational teams.
  • Experience supporting early-stage health authority interactions, including pre-IND and Type B/C/D meetings and FDA/NCA/EMA scientific advice.
  • Experience overseeing clinical data management and systems (EDC, CDISC standards, analytics/reporting platforms) and aggregate safety reporting (e.g., DSURs), with the ability to translate CRO/EDC data flows into decision-ready reporting.
  • Exceptional communicator who translates complex statistical and analytical concepts for non-technical audiences and presents confidently at governance and investment forums.
  • 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.

Benefits

  • Partner with Clinical, Regulatory, Medical, Translational, CMC, and Business Development teams, and oversee CROs and vendors across biometrics activities.
  • 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.
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