Associate Director - Data Standards (Hybrid)

Lead, manage and develop a group of data standards experts to develop, implement and maintain end-to-end data standards from data collection to regulatory submission. Govern change control, publication and communication of new and updated data standards.

Responsibilities:
- Ensure compliance with applicable Corporate and Divisional policies and procedures
- Maintain in-depth knowledge of CDISC guidance/implementation guides and FDA guidance/regulations for electronic submissions; track trends in data mapping, data management, standards compliance methodologies, metadata management and data warehousing
- Review eCRF designs for conformance to CDASH/SDTM; proactively identify and correct design limitations/flaws
- Review SDTM conformance mapping specifications; provide CDISC expertise for cross-functional mapping of source data to SDTM
- Execute and interpret CDISC validation tools (define.xml for SDTM and ADaM); collaborate to resolve issues and document unresolved items (e.g., FDA Data Reviewer's Guides)
- Manage CDISC metadata/terminology/standards in a metadata repository; provide governance oversight
- Assist in development of data standards policies/procedures/practices
- Communicate clinical data standards concepts and regulatory guidance; present arguments to cross-functional stakeholders; represent Data Standards group interests
- Ensure training compliance; mentor data standards staff; train new analysts
- Support CDISC external involvement: consolidated review comments for public standards; submit at least one abstract/year for CDISC Interchange

Qualifications:
- B.S.; 12+ years relevant clinical research experience (or 10+ with a Masters)
- Expert in at least 3 areas of clinical data standards (CDASH, SDTM, ADaM, define.xml, controlled terminology, metadata management) and high-level knowledge in one additional area
- Familiarity with BRIDG, ODM, SHARE
- Experience mapping/converting legacy data into SDTM domains for eCTD; minimum two successful CDISC-compliant submissions
- Knowledge of international regulations/guidance for clinical data standards and regulatory dataset preparation
- Experience with metadata repository technology and governance; metadata management to support systems/processes

Benefits (as listed): paid time off; medical/dental/vision insurance; 401(k); eligible for long-term incentive programs