Lead Standards team under DSO (Data Standards and Operations) to ensure the implementation and compliance of data standards within B&P(Biostatistics and Programming). Collaborates with global standards organization CIG (Clinical Information Governance) to manage all aspects of data standards queries and needs within B&P. Expands and mentors the standards team by developing expertise in CDSIC and submission standards required by Health Agencies. Develops process to support centralized submission project delivery. Collaborates with the ART (Analysis and Reporting Tools) team to develop and maintain global reporting standard metadata end to end.
- Leads global ADaM team and manages the bi-annual ADaM standards release, support study team queries.
- Leads site SMEs to develop standards training and provide process improvement.
- Partners with the ART team to develop submission tools to support a centralized submission process.
- Collaborates with ART team to define, maintain, and provide an impact analysis of Reporting standard metadata in support for an end to end automation projects, including but not limited to MAP (Metadata Assisted Programming), de-identification.
- Develops new or TA specific standards.
- Advocates standards and ensure implementation within B&P.
- Interacts with internal regulatory and external standards organization and health agencies for standards updates and submission requirements.