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:
- Responsible for compliance with applicable Corporate and Divisional policies and procedures.
- Maintain complete, in-depth understanding of CDISC guidance/implementation guides and FDA guidance/regulations for electronic data submission; stay current on industry trends in data mapping, data management, standards compliance, metadata management and data warehousing.
- Demonstrate extensive understanding of CDASH and SDTM; review eCRF designs for CDASH/SDTM compatibility and proactively correct flaws.
- Demonstrate extensive understanding of SDTM, Standard Terminology and coding dictionaries; review and correct SDTM conformance mapping specifications; provide CDISC expertise for cross-functional source-to-SDTM mapping.
- Interpret results from SDTM/ADaM validation tools and associated define.xml; execute validation tools; collaborate to resolve issues; document unresolved issues (e.g., in the FDA Data Reviewers’ Guides).
- Manage CDISC-related metadata/terminology/standards within a metadata repository; provide governance oversight to ensure metadata consistency.
- Assist in development of data standards policies, procedures and practices.
- Communicate clinical data standards concepts and regulatory guidance; present logical arguments to statistical programmers, statisticians, data scientists, clinical development and regulatory.
- Mentor team members; train new analysts on processes and systems for managing/implementing data standards.
- Support CDISC external involvement: consolidate review comments for applicable standards and submit at least one abstract per year to a 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 (e.g., 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 two successful CDISC-compliant submissions.
- Knowledge of international regulations/guidance for clinical data standards and preparation of data sets for regulatory submission.
- Experience with metadata repository technology and data standards governance; experience managing metadata to support systems/processes.