Data Standards Analyst

Job title: Data Standards Analysts

• Location:IN / Hyderabad

• Grade:  L1-2

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 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  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

• Experience:  Experience in Pharmaceutical Industry, with strong involvement in the “clinical data flow”, specialized in Data Standards Management.

• Good knowledge of industry data standards and practices (e.g., CDISC/CDASH/SDTM). Good understanding of CDISC 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: Bachelor’s degree or above, preferably in Life Science or related field

• Languages:  Excellent English language knowledge – written and spoken.