Senior Data Standards Analyst

Data Standards Analyst supports clinical teams serving as a Subject Matter Expert (SME) during the review of study-specific metadata based on customer needs and provides effective solutions 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 Sr.
Data Standards Analyst and youll help shape the future of Clinical Data Standards at Sanofi and across our industry..
Main Responsibilities.
Acts as a Metadata Lead Expert for CDASH, SDTM, External Data or Controlled Terminology..
Understands the application of the CDISC models across the life cycle of a trial..
Leads Global/Study Request Review Meetings for the specific Data Standards Model of expertise..
Provides SME expertise 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..
Support other Clinical Data StandardLeaders with the management of global requests (review/meeting/implementation in Sanofi Metadata/metadata QC/standard documentation updates)..
Participatein 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.
Experience: Experience in Pharmaceutical Industry, with strong involvement in the clinical data flow, specialized in Data Standards Management..
Strong knowledge of industry data standards and practices (e.g., CDISC/CDASH/SDTM).
Having strong level of CDISC skills and Metadata Governance practices.
(Preferred CDISC certification in one of more of the models)..
Good understanding of end-to-end clinical data flows and data structures..
Soft and technical skills: Strong English skills (verbal and written), ability to exchange fluently in a global environment..
Efficient communication skills and good organization skills..
Ability to negotiate and gain acceptance of others..
Ability to coordinate/oversee multiple tasks simultaneously..
Project team collaboration by interacting with internal or external partners in/outside the Department and with their leaders..
Self-motivated results driven with attention to detail and quality..
Education: Bachelors degree or above, preferably in Life Science or related field.
Languages: Excellent English language knowledge written and spoken..
Show more Show less