Associate Director - Data Standards (Hybrid)
Core
Lead and manage a group of data standards experts to develop, implement, and maintain end-to-end data standards from data collection to regulatory submission, ensuring compliance with CDISC guidance and FDA regulations.
Role type
Senior management-level clinical data standards expert
Builds
CDISC-compliant data sets for regulatory submissions (eCTD)
Domain
Clinical research data management and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Expert knowledge of CDASH, SDTM, ADaM, define.xml, controlled terminology, and metadata management; experience mapping legacy data to SDTM domains; proficiency with CDISC validation tools; experience managing metadata repositories; ability to mentor teams and present to cross-functional groups
Preferred skills
Familiarity with BRIDG, ODM, and SHARE standards; experience with international regulations for clinical data standards
Technologies
CDISC standards (CDASH, SDTM, ADaM), define.xml, metadata repository technology, validation tools
Responsibilities
Govern change control and publication of data standards; critically review eCRF designs for conformance; execute validation tools and resolve identified issues; manage libraries of CDISC-related metadata; develop data standards policies and procedures; mentor Data Standards Analysts and Managers; represent the Data Standards group in cross-functional initiatives
Seniority
Senior, hands-on IC with management responsibilities