Associate Director, Clinical Data Standards & Governance

The Associate Director, Clinical Data Standards and Governance is a hands-on subject-matter expert who leads the design, implementation, and lifecycle governance of clinical data standards across the enterprise data value chain — from protocol concept and collection through acquisition, tabulation, analysis, and regulatory submission.

This role owns the standards library and governance mechanics that keep it current, including version control, change and exception workflows, regulatory surveillance, and compliance metrics. The position partners across Clinical Data Management, Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Quality, and IT/Data Engineering to ensure standards are authored once and reused consistently across studies.

It is an individual-contributor leadership role with responsibility for chairing or driving technical working groups, setting technical direction, and maintaining an active presence in the external CDISC standards community.

Key responsibilities include:

• Owning and maintaining the enterprise standards library across collection, acquisition, tabulation, and analysis layers
• Authoring sponsor SDTM/ADaM conventions, controlled terminology mappings, and eCRF/CDASH specifications
• Managing standards governance, change control, and exception workflows end to end
• Maintaining Define-XML, SDRG, and ADRG templates and conventions
• Supporting audits, inspections, and regulatory surveillance
• Improving metadata repository processes, validation rules, and standards-compliance tooling
• Driving training, adoption, and cross-functional implementation support
• Representing the organization in the broader CDISC community