Vice President, Biometrics and Clinical Analytics

The role

The VP of Biometrics and Clinical Analytics provides leadership across biostatistics, clinical programming, data management, and safety. This person will design studies, manage vendor sourcing, and deliver real-time visibility into clinical and operational data.

What you will do

• Serve as senior biometrics lead across programs to shape development strategy and trial design.
• Contribute to Phase I/II design including adaptive and Bayesian methodologies.
• Develop and review statistical sections of protocols, SAPs, and CSR/regulatory documents.
• Support health authority interactions and SRC/DMC/DSMB activities.
• Establish standards, processes, and vendor frameworks.
• Build, hire, and mentor an internal biometrics team over the long term.
• Define and implement biometrics sourcing model for CROs, FSPs, and consultants.
• Oversee clinical data management, safety data, and the systems ecosystem.
• Maintain biometrics SOPs and data standards.
• Build near-real-time visualizations and operational dashboards from CRO-sourced data.

Required qualifications

• PhD or MS in Biostatistics, Statistics, or related quantitative discipline.
• 12+ years in biometrics (biotech/pharma).
• 5+ years leading statistical strategy and modern trial methodologies for Phase I/II programs.
• Hands-on experience on early-stage (first-in-human to proof-of-concept) programs.
• Success in lean or startup environments.
• Proficiency in statistical programming (R and/or SAS).
• Experience building interactive data visualizations and operational dashboards (e.g., Spotfire, Tableau, Power BI, R Shiny).
• 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).
• 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 capacity.
• Exceptional communicator who translates complex statistical and analytical concepts for non-technical audiences.

Benefits

• medical
• dental
• vision
• 401k

About the company

Aditum Bio is a firm that in-licenses promising therapies to translate scientific discoveries into new medicines. It was co-founded by Joe Jimenez and Mark Fishman.