Clinical Data Standards Lead: SDTM/ADaM Governance

Pierre Fabre Pharmaceuticals, Inc.

Friauville

Hybrid

EUR 90,000 - 120,000

Full time

6 days ago

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Job summary

Pierre Fabre Laboratories is seeking a Clinical Data Standards Lead to champion a company-wide standards framework within the Biometry Department. You will own sponsor standards, define metadata, and drive harmonisation across data managers, programmers, statisticians and clinical operations to support submission readiness and data reuse.

The role offers the chance to build a sponsor-owned capability, shape regulatory-aligned processes, and enable automation and AI-enabled clinical development

Qualifications

Advanced degree in life sciences, data management, statistics, programming or related field.
Minimum of 10 years in the pharmaceutical industry or CROs.
Strong experience with clinical trials, ideally oncology.
Hands-on in developing sponsor standards including eCRF/CDASH, SDTM and ADaM.

Responsibilities

Define, implement and govern the Clinical Data Standards Strategy.
Own and evolve sponsor standards library (CDISC-based) and change management.
Lead adoption across internal teams, CROs and external partners.
Provide training and coaching on data standards and governance.
Represent Pierre Fabre in external standards initiatives and industry forums.

Skills

Advanced degree in life sciences

Pharmaceutical industry experience

Clinical data standards knowledge

CDISC standards familiarity

Education

Master's Degree or PhD in life sciences

Tools

CDISC standards

Job description

The role offers the chance to build a sponsor-owned capability, shape regulatory-aligned processes, and enable automation and AI-enabled clinical development

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