Sanofi Logo

Sanofi

Senior Data Standards Analyst

Job Posted 18 Days Ago Posted 18 Days Ago
Be an Early Applicant
Hyderabad, Telangana
Senior level
Hyderabad, Telangana
Senior level
The Senior Data Standards Analyst acts as a metadata expert in the Clinical Information Governance team, providing guidance on clinical data standards and leading governance initiatives for CDISC models. This role involves monitoring regulatory requirements, supporting clinical teams with study-specific metadata, and promoting best practices in data management across global studies.
The summary above was generated by AI

Job title: Senior Data Standards Analyst

  • Location: IN / Hyderabad

  • Grade:  L2-1

About the job
As a member of a CIG (Clinical Information Governance) team, the Sr. 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 the governance of one of the CDISC Data Standards models (CDASH, SDTM, External Data or Controlled Terminology) across Therapeutic Areas. The Sr. Data Standards Analyst will bridge the gaps between global metadata strategy and its adoption within therapeutic area studies.
The Sr. 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 Sr. 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 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 Sr. Data Standards Analyst and you’ll 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 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.

  • • 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: Bachelor’s degree or above, preferably in Life Science or related field

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

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Top Skills

Cdash
Cdisc
Sdtm

Sanofi Hyderabad, Telangana, IND Office

Hyderabad, Telangana, India

Similar Jobs

7 Days Ago
Hyderabad, Telangana, IND
Junior
Junior
Healthtech
The Data Standards Analyst supports the Clinical Information Governance team by developing and governing clinical data standards and best practices for metadata management, as well as contributing to governance of CDISC models. Responsibilities include reviewing study-specific metadata, collaborating with clinical teams, and aligning data standards strategies across therapeutic areas.
Top Skills: CdashCdiscSdtm
Yesterday
Hybrid
Hyderabad, Telangana, IND
Mid level
Mid level
Financial Services
As a KYC Manager, you will lead compliance efforts in managing KYC records, ensuring adherence to regulations, and providing support to the team. Responsibilities include conducting detailed reviews, analyzing discrepancies, collaborating with cross-functional teams, and staying updated with regulatory changes. Your role emphasizes risk management and the enhancement of KYC processes.
Top Skills: Kyc
2 Days Ago
Hyderabad, Telangana, IND
Mid level
Mid level
Big Data • Fintech • Information Technology • Insurance • Financial Services
The Senior Analyst, Operations will analyze processes related to US Life/Annuity transactions, ensuring compliance with SLAs while providing excellent customer service and maintaining quality standards. Responsibilities include problem-solving, time management, and effective communication to enhance operational efficiency.

What you need to know about the Hyderabad Tech Scene

Because of its proximity to leading research institutions and a government committed to the city's growth, Hyderabad's tech scene is booming. With plans to establish India's first "AI city," the city is on track to become one of the world's most anticipated tech hubs, with companies like TransUnion, Schrödinger and Freshworks, among others, already calling the city home.
By clicking Apply you agree to share your profile information with the hiring company.

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account