Principal Data Standards Analyst (SDTM Programmer)

Grade: L2-2

As Principal Data Standards Analyst within our Clinical Information Governance, As a member of a CIG (Clinical Information Governance) team, the Principal Data Standards Analyst acts as a metadata expert as he/she provides in-depth knowledge and guidance on 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 leads Therapeutic Area Working Groups. The Principal Data Standards Analyst will bridge the gaps between global metadata strategy and its adoption within therapeutic area studies.

The Principal 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 Principal Data Standards Analyst supports clinical teams in supervising 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 medicine? The 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 Principal Data Standards Analyst and youll help shape the future of Clinical Data Standards at Sanofi and across our industry.

• Acts as a Metadata Lead Expert for CDASH, SDTM, External Data and Controlled Terminology.
• Understands the application of the CDISC models across the life cycle of a trial.
• Leads Global/Study Request Review Meetings. Leads eCRF review (study level) with the Study Team and ensure study-specific metadata are aligned with the CIG Clinical Data Standards strategy.
• Review of study requests (Data Collection, External Data, Controlled Terminology, SDTM).
• Develop CDISC-compliant end-to-end metadata specifications for new study-specific forms.
• May lead the creation and upload of study-specific controlled terminology (CT) in the Clinical Data Repos system.
• Support 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.

• Experience: Relevant professional 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 High level CDISC skills and Metadata Governance practices. (Preferred CDISC certification in one of more of the models).
• Familiar with 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.

This role is critical to our teams success and provides exposure to industry-wide developments of Data Standards. It is an opportunity to become a leader within a network of subject matter experts collaborating to shape the future of Data Standards for Clinical Research.