Associate Director, Biomedical Data Stewardship (Standards Lead)
Core
Lead the India-based Biomedical Data Stewardship (BMDS) standards team to advance consistent clinical data standards across the drug development lifecycle.
Role type
Senior IC standards lead (clinical data)
Builds
Clinical data standards, metadata repositories, and regulatory submission deliverables (SDTM, ADaM) for global drug development
Domain
Biopharmaceuticals / Clinical Data Management
Required skills
Clinical data standards (SDTM, ADaM, CDISC), team leadership, cross-functional collaboration, governance, regulatory compliance, process improvement
Preferred skills
Master's degree, global clinical development organization experience, budget/resource planning, inspection readiness
Technologies
CDISC, SDTM, ADaM, metadata repositories
Responsibilities
Lead the India-based BMDS standards team; translate global strategy into delivery plans; act as liaison with Clinical Data Management, Programming, Biostatistics, and Regulatory Writing; lead data standards governance forums; oversee specialists in standards development and maintenance; assess emerging industry standards; establish adoption measures; sponsor governance process improvements; represent BMDS in external forums
Seniority
Senior, hands-on IC with management responsibilities