Clinical Data Standards Lead - Global Strategy & Governance

Pierre Fabre Laboratories

Île-de-France

On-site

EUR 90,000 - 140,000

Full time

6 days ago

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Job summary

Pierre Fabre Laboratories is seeking a highly skilled Clinical Data Standards Lead within the Biometry Department to harmonise and implement a company-wide standards framework. You will partner with Data Managers, Programmers, Statisticians, Clinical Development, Regulatory Affairs, Medical Writing, and IT teams to shape metadata and the technology ecosystem.

The role offers visibility to sponsor-wide standards, driving automation, data reuse, and submission readiness, with a hands-on leadership

Qualifications

Advanced degree in life sciences, data management, statistics, programming (Master’s Degree or PhD) or a related field.
A minimum of 10 years of experience in the pharmaceutical industry and/or within laboratories (Sponsors) and CROs.
Strong experience in clinical trials, ideally in oncology.
Hands-on experience developing and implementing sponsor standards, including eCRF/CDASH, SDTM, ADaM, terminology, metadata and submission deliverables.

Responsibilities

Define and govern the Clinical Data Standards Strategy.
Own the Sponsor Standards Library built on CDISC standards.
Establish governance, lifecycle, version control and change management practices.
Lead development and governance of standards covering eCRF libraries, SDTM, ADaM, terminology and study metadata.
Ensure standards support regulatory expectations and submission deliverables.