Clinical Data Standards Leader: SDTM/ADaM Governance

PIERRE FABRE MEDICAMENT; Pechbusque; On-site; EUR 110,000 - 150,000; Full time

Job summary

Pierre Fabre Laboratories is seeking a senior Clinical Data Standards Lead for its Biometry Department in France. You will define and govern the clinical data standards strategy, own the sponsor standards library, and drive harmonisation across data managers, programmers and clinical teams to support quality and submission readiness.

You will build a scalable metadata and technology ecosystem, ensuring standards enable automation, data reuse, and regulatory alignment while collaborating with

Qualifications

• Advanced degree in life sciences, data management, statistics, programming or related field.
• At least 10 years of pharma industry or CRO experience.
• Hands-on experience with sponsor data standards (eCRF/CDASH, SDTM, ADaM, terminology) and submission artefacts.

Responsibilities

• Define and govern Clinical Data Standards Strategy.
• Own the Sponsor Standards Library built on CDISC standards.
• Establish governance, lifecycle management and change processes for standards.
• Develop and maintain standards for eCRF, SDTM, ADaM, terminology and study metadata.
• Lead adoption across internal teams and partners; train and mentor colleagues.

Skills

Clinical data standards

CDISC standards

SDTM/ADaM

Regulatory knowledge

Stakeholder collaboration

Education

Advanced degree in life sciences, data management, statistics, programming (Master's or PhD)

Job description

Pierre Fabre Laboratories is seeking a senior Clinical Data Standards Lead for its Biometry Department in France. You will define and govern the clinical data standards strategy, own the sponsor standards library, and drive harmonisation across data managers, programmers and clinical teams to support quality and submission readiness.

You will build a scalable metadata and technology ecosystem, ensuring standards enable automation, data reuse, and regulatory alignment while collaborating with