Senior Biometrics Transformation Lead - M/W (CDI)
Core
Lead the transformation of the biometrics operating model for clinical development, statistics, and statistical programming to improve delivery predictability, quality, and governance.
Role type
Senior transformation lead (biometrics/statistics)
Builds
Scalable, inspection-ready operating models for clinical data management, statistics, and regulatory submissions
Domain
Pharmaceutical R&D (Oncology, Dermatology, Rare Diseases)
Required skills
Biometrics strategy, statistical programming oversight, clinical trial design, CDISC standards (SDTM/ADaM), SAS/R/Posit, vendor/CRO governance, GxP compliance, change management, stakeholder alignment
Preferred skills
Automation/GenAI implementation in GxP, oncology/dermatology/rare diseases experience, formal project/program management training
Technologies
SAS, R/Posit, CDISC SDTM, CDISC ADaM, USDM
Responsibilities
Lead execution of biometrics transformation roadmap; define governance mechanisms and RACI models; prioritize competing initiatives; support internalization of high-value activities; champion adoption of data standards and modern computing environments; facilitate senior-level workshops; monitor transformation KPIs; provide executive decision support.
Seniority
Senior, hands-on IC with leadership scope
