Associate Director, Data Standards

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 understanding of CDISC guidance/implementation guides and FDA guidance/regulations for electronic data submission; stay current on trends in data mapping, data management, standards compliance, metadata management, and data warehousing
- eCRF design: review eCRF designs for compatibility/conformance with CDASH/SDTM and proactively fix issues/limitations
- SDTM conformance mapping: review mapping specifications, correct flaws, and provide CDISC expertise for cross-functional mapping of source data to SDTM
- CDISC validation tools: interpret results for SDTM/define.xml and ADaM/define.xml; execute validation tools; resolve issues and document unresolved issues (e.g., FDA Data Reviewer’s Guides)
- Metadata repository: manage CDISC-related metadata libraries/terminology/standards; provide governance oversight to ensure metadata consistency
- Assist in development of data standards policies, procedures, and practices
- Communicate data standards concepts and regulatory guidance; present arguments to cross-functional partners and represent the Data Standards group in initiatives
- Training & mentoring: comply with training requirements; mentor and train Data Standards staff on processes/systems
- CDISC involvement: consolidate review comments for public CDISC standards and submit at least one abstract per year for CDISC Interchange

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

Benefits:
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k)
- Eligible for long-term incentive programs