Responsibilities
- 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.
- Responsible for compliance with applicable Corporate and Divisional Polices and procedures - Industry Standards
- Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides as well as FDA guidance and regulation regarding electronic submission of data. Keeps abreast of industry trends in data mapping, data management, standards compliance methodologies, metadata management and data warehousing.
- eCRF Design - Demonstrates extensive understanding of CDASH and SDTM standards and concepts. Able to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards. Recognizes limitations if eCRF design and correct flaws proactively.
- SDTM Conformance Mapping - Demonstrate extensive understanding of SDTM, Standard Terminology and common coding dictionaries. Reviews SDTM conformance mapping specifications and corrects flaws proactively. Provide input and CDISC expertise to cross-functional activities such as mapping of source data to SDTM.
- CDISC Validation Tools - Demonstrates knowledge of rules for SDTM and the associated define.xml file or rules for ADaM and the associated define.xml file and able to appropriately interpret results from common validation tools. Executes validation tools and collaborates with other functions to resolve identified issues. Ensure any unresolved issues are appropriately documented (for example in the FDA's Data Reviewer's Guides)
- Metadata Repository - Responsible for managing libraries of CDISC-related metadata, terminology and related standards within the metadata repository. Provides governance oversight to Manager, Data Standards to ensure consistency in metadata.
- Policies & Procedures - Assist in the development of data standards policies, procedures and practices.
- Communication - Clearly communicates an understanding of clinical data standards concepts, clinical principles, and regulatory guidance and acts in accordance with those principles. Effectively presents data standards concepts and logical arguments to statistical programmers, statisticians, data scientists, clinical development and regulatory. Able to diplomatically and persuasively represent the interests of the Data Standards group in cross-functional initiatives.
- Training & Mentoring - Be compliant with training requirements. Effectively mentor peers, Manager, Data Standards, Sr Data Standards Analysts and Data Standards Analysts with regard to data standards and functional operations. Train new Data Standards Analysts on process and systems related to the management and implementation of data standards.
- CDISC involvement - Maintains external reputation of a clinical data standards expert. Ensures consolidated review comments from Data Standards group and Statistical Programming are provided for applicable CDISC standards released for public review. Submits at least one abstract per year for presentation at a CDISC Interchange.
Requirements
- Extensive understanding of CDISC guidance documents and implementation guides
- Knowledge of FDA guidance and regulation regarding electronic submission of data
- Extensive understanding of CDASH and SDTM standards and concepts
- Ability to critically review eCRF designs for CDASH/SDTM conformance
- Understanding of SDTM, Standard Terminology, and common coding dictionaries
- Ability to review SDTM conformance mapping specifications
- Knowledge of rules for SDTM and ADaM and associated define.xml files
- Ability to interpret results from common validation tools
- Experience executing validation tools and resolving issues
- Experience managing CDISC-related metadata and terminology in a metadata repository
- Ability to provide governance oversight to ensure metadata consistency
- Experience assisting in development of data standards policies and procedures
- Strong communication skills to present data standards concepts to cross-functional teams
- Ability to mentor team members and train new analysts
- Active participation in CDISC, including submitting abstracts annually
Work Arrangement
Hybrid
