Principal Data Standards Analyst (Laboratory Expert)

About the job

Title:Principal Data Standards Analyst (Laboratory Expert)

Level : L2-2

The Principal Data Standards Analyst (Laboratory Expert) plays a crucial role in ensuring the accurate standardization, integration, and management of laboratory data across clinical studies. This role supports Clinical Information Governance (CIG), Trial Operations (TO), Data integration, Translational Medicine, Sample Management, and external vendors, ensuring compliance with CDISC standards (SDTM, CDASH, Controlled Terminology) and regulatory requirements.

The Principal Data Standards Analyst (Laboratory Expert) also provides specialized oversight on laboratory data handling, collaborating with internal teams and external central laboratories to mitigate risks related to biomarker, genomic, and flow cytometry data. This role is instrumental in managing laboratory data mapping, governance, and compliance to support regulatory submissions and clinical study execution.

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:

1.    Laboratory Data Standards & Compliance

·       Map laboratory test names, units, conversion factors, and other parameters to CDISC Standard Controlled Terminology (CT) across Safety and Efficacy Labs, Biomarkers, Microbiology, Microscopy, Genotyping, Cell Phenotyping, Immune Responses, etc.

·       Develop, review, and validate laboratory data mappings for compliance with CDISC Standard Controlled Terminology, SDTM and regulatory requirements (FDA, EMA, PMDA).

·       As a Lab expert, contributes to study and/or global request requiring lab expertise.

·       Ensure alignment of laboratory data with LOINC and other standard dictionaries.

·       Work closely with the Data Integration Team to standardize and map laboratory terminology to CDISC Controlled Terminology.

·       Provide recommendations for new or modified laboratory data standards based on industry trends and regulatory requirements.

2.    Laboratory Data Management & Vendor Oversight

·       Act as the Central Lab Co-Business Leader within Trial Operations (TO), overseeing central laboratory service providers.

·       Provide direct support to study teams in resolving escalated laboratory data issues.

·       Identify high business risk laboratory issues, implement mitigation plans, and coordinate with CQ&CI Management.

·       Support vendor qualification, selection, and reassessment of central laboratories for Sanofi studies.

·       Ensure laboratory data integrity in file transfer specifications (FTS), collaborating with external vendors and Data Integration teams.

·       Represent Clinical Data & AI Processing (CDAIP) in Central Laboratory Governance Meetings and other affiliated working groups.

3.    Cross-functional Collaboration & Study Execution Support

·       Advise Trial Operations, Translational Medicine, and Biomarker teams on laboratory data requirements.

·       Collaborate with Sample Management teams on sample handling, tracking, and storage strategies.

·       Provide expertise to ensure accurate clinical database setup for laboratory tests, SI units, and conversion factors.

·       Participate in regulatory submissions, ensuring laboratory datasets meet CDISC and regulatory requirements.

·       Participate in Standards governance reviews to maintain and update standards libraries, ensuring consistency across the clinical lifecycle.

·       Support non-standard studies requiring specialized laboratory data handling.

4.    Training, Governance, & Continuous Improvement

·       Develop SOPs, best practices, and training materials for laboratory data standardization.

·       Provide training and mentorship on laboratory test mapping processes and CDISC Standard Controlled Terminology (CT) implementation.

·       Monitor industry trends, participate in CDISC working groups (including the CT group), and engage with external industry forums.

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

About you

• Experience: Years of experience in clinical data standards and laboratory data.

• Strong knowledge of CDISC SDTM, CDASH, and Standard Controlled Terminology.

• Strong experience with laboratory data(Safety and Efficacy Labs, Biomarkers, Microbiology, Microscopy, Genotyping, Cell Phenotyping, Immune Responses, etc.)

• Strong understanding and experience with regulatory data submission and requirements.

• Strong and clear understanding of vendor Laboratory terminology and nomenclature. As well as Laboratory dictionaries such as LOINC.

• Soft and technical skills: Proficiency in data handling tools (Excel, SAS, Python, etc.) for dataset transformation and validation.

• Familiarity with MedDRA, WHODrug, and other clinical terminology standards.

• Experience with metadata repositories and clinical data management systems (e.g., Medidata Rave) is a plus.

• Certification in CDISC SDTM, CDASH, or Data Standards is a plus.

• Knowledge of regulatory submission requirements (e.g., FDA, PMDA, EMA).

• Good and clear understanding of vendor Laboratory terminology and nomenclature

• Strong English skills (verbal and written), ability to exchange fluently in a global environment.

• Ability to negotiate and gain acceptance from 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.

• Strong analytical and problem-solving skills with high attention to detail.

• Ability to work independently and collaboratively in a cross-functional team.

• Excellent communication skills for interacting with technical and non-technical stakeholders. 

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

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

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave.
  “This role is critical to our team’s 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.”.