Data Standards Analyst

About the job

As a member of a CIG (Clinical Information Governance) team, the Data Standards Analyst supports the metadata Leads and Seniors as he/she contributes to the development and governance of clinical data standards (CDISC) and best practices for metadata management across global and study-specific levels


Understand the CDISC models (CDASH, SDTM, External Data, Controlled Terminology) and all regulatory requirements regarding Data Standards


Actively contributes to the governance of one of the CDISC Data Standards models (CDASH, SDTM, External Data or Controlled Terminology) across Therapeutic Areas

The Data Standards Analyst will help bridge the gaps between global metadata strategy and its adoption within therapeutic area studies



The Data Standards Analyst represents Sanofi in all internal external networks initiatives (CDISC, TransCelerate, etc

), monitor actively Health Authorities requirements, and promotes Data Standards knowledge and best practices within Sanofi


At the study level, the Data Standards Analyst supports clinical teams and Standards leads during the review of study-specific metadata based on customer needs and provides effective input through regular analysis of information reported from a broad variety of sources



Are you ready to shape the future of medicineThe race is on to speed up drug discovery and development to find answers for patients and their families

Your skills could be critical in helping our teams accelerate progress

Join our Clinical Information Governance team as Data Standards Analyst and you ll help shape the future of Clinical Data Standards at Sanofi and across our industry



Main responsibilities :

Supports the Metadata Leads for CDASH, SDTM, External Data or Controlled Terminology


Understands the application of the CDISC models across the life cycle of a trial


Contributes to the support of Global/Study Request Review Meetings for the specific Data Standards Model of expertise


Provides input during the eCRF review (study level) with the Study Team and ensures study-specific metadata are aligned with the CIG Clinical Data Standards strategy


Review of study requests (Data Collection, External Data, Controlled Terminology or SDTM)


Contributes to develop CDISC-compliant end-to-end metadata specifications for new study-specific forms


Supports Clinical Data Standard Leaders with the management of global requests (review/meeting/implementation in Sanofi Metadata/metadata QC/standard documentation updates)


Participate in Core and TA standard needs definition (SDTM and TA WG)
Contribute to Global governance process definition and/or optimization


Monitor study-specific forms developed with Standard potential at the Therapeutic Area level



About you