Sanofi Group Senior Submission Data Standards Leader in Bridgewater, New Jersey
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.
Required Knowledge and Skills:
MS / BS with at least 8+ / 10+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.
Thorough understanding of pharmaceutical clinical development and regulatory submission process.
Expert and proven knowledge in CDISC data standards (CDASH, SDTM, ADaM, CT) and submission requirements (SDSP, aCRF, define.xml, cSDRG, ADRG, etc.). Proven success in leading standards development and implementation projects.
Good understanding of the statistical reporting process and the link between ADaM and standard TLFs a must.
Up-to-date knowledge of regulatory requirements concerning electronic submission standards with particular emphasis on all FDA guidance related to submission of standardized study data and portable document specifications.
Demonstrated project leadership, project management, interpersonal skills, and good teamwork
Excellent verbal and written communication skills in an English global environment.
Ability to have efficient exchanges with external stakeholders and colleagues across geographical locations.
Understanding of relational database structures and their correlation to submission-ready database structures. Understanding of graph database query language, CDISC 360 content and structure highly desired.
Proficient skills of Microsoft Excel functionality, SAS programming language including SAS macro processing.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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