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:
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures
- Maintain in-depth knowledge of CDISC guidance and implementation guides; FDA guidance for electronic data submission; stay current on industry trends (data mapping, data management, standards compliance, metadata management, data warehousing)
- Demonstrate extensive understanding of CDASH and SDTM; review eCRF designs for CDASH/SDTM compatibility; proactively correct issues
- Review SDTM conformance mapping specifications; provide CDISC expertise for mapping source data to SDTM
- Understand validation rules for SDTM/define.xml and ADaM/define.xml; execute validation tools; resolve issues; document unresolved issues (e.g., FDA Data Reviewer's Guides)
- Manage CDISC metadata/terminology libraries in the metadata repository; provide governance oversight
- Assist in developing data standards policies, procedures and practices
- Communicate clinical data standards concepts and regulatory guidance to cross-functional teams
- Mentor/Train data standards staff; ensure training compliance
- Participate in CDISC activities; provide consolidated review comments; submit at least one abstract per year to a CDISC Interchange

Qualifications:
- B.S.
- 12+ years clinical research experience (or 10+ years with a Master’s)
- Expert in at least 3: CDASH, SDTM, ADaM, define.xml, controlled terminology, metadata management; high knowledge in one additional area
- Familiarity with BRIDG, ODM, SHARE
- Experience mapping/converting legacy data into SDTM 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; data standards governance; metadata management

Benefits:
- Paid time off; medical/dental/vision insurance; 401(k)
- Eligible for long-term incentive programs

Application instructions:
- Not provided.