Clinical Data Standards Lead -M/F- CDI

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

Who we are ?

We are Pierre Fabre Laboratories, a global leader combining pharmaceutical expertise with dermo-cosmetics to support consumers and patients at every stage of their care journey. Our portfolio includes several medical franchises and international brands such as Eau Thermale Avène, Ducray, A-Derma, Klorane, René Furterer, and Pierre Fabre Oral Care. By joining us, you become part of a meaningful company where the human dimension is essential. You become a participant in the 'We Care Movement,' a movement that values excellence and innovation within passionate teams. Together, we push the boundaries of science to unite health and beauty for the benefit of all, because Every time we care for a single person, we make the whole world better.

Present in 120 countries with a team of over 10,000 employees, we are proud to create a scientific and human impact, today and tomorrow! If caring is at the heart of your values, join Pierre Fabre Laboratories and become a key player in the “We Care Movement”.

Your mission Pierre Fabre is a global pharmaceutical company dedicated to the research, development, and commercialization of innovative drugs. Our Biometry Department is integral to our success, providing comprehensive support for all drug development initiatives, including Randomized Controlled Trials (RCTs) and Real World Evidence (RWE) studies. We are seeking a highly skilled and proactive Clinical Data Standards Lead to join our Biometry Department. The successful candidate will serve as the internal representative and owner for clinical data standards, leading the harmonisation and implementation of a company‑wide clinical data standards framework, and working closely with Data Managers, Statistical Programmers, Statisticians, Clinical Development, Clinical Operations, Regulatory Affairs, Medical Writing, Data Science, Digital Technology teams, CROs and external partners. This role offers the opportunity to build a sponsor‑owned clinical data standards capability from the ground up, shape the associated metadata and technology ecosystem, and directly influence how Pierre Fabre modernizes clinical development. The successful candidate will have the visibility and mandate to turn standards into a strategic capability supporting quality, submission readiness, automation and data reuse.

Your role within a pioneering company in full expansion: Clinical Data Standards, Strategy, Governance and Metadata

• Lead the definition, implementation and governance of Pierre Fabre's Clinical Data Standards Strategy.
• Own and evolve the Pierre Fabre Sponsor Standards Library built on top of CDISC standards, including therapeutic‑area specific standards where appropriate.
• Establish standards governance processes, lifecycle management, version control and change management practices.
• Lead the development, maintenance and governance of standards covering eCRF libraries, SDTM, ADaM, edit checks, controlled terminology and study metadata.
• Ensure Pierre Fabre standards remain aligned with evolving regulatory expectations and industry best practices.
• Ensure standards support key submission deliverables, including annotated CRFs, Define.xml and data reviewer guides.

Adoption, Transformation & Collaboration

• Lead the adoption of Pierre Fabre standards across internal teams, CROs and external partners.
• Build strong partnerships with Data Management, Programming, Statistics, Clinical Development, Regulatory Affairs, Medical Writing and R&D IT teams to ensure standards are practical, scalable and operationally efficient.
• Deliver training, coaching and mentoring in clinical data standards and governance.
• Ensure Pierre Fabre standards support future automation, reusable analytics, digital data flow and AI‑enabled clinical development processes.
• Represent Pierre Fabre in relevant external standards initiatives, working groups and industry forums.

Who you are ?

Your skills at the service of innovative projects:

• 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 Contract Research Organizations (CROs).
• Strong experience in clinical trials, ideally in oncology.
• Demonstrated hands‑on experience developing and implementing sponsor standards, including eCRF/CDASH, SDTM, ADaM, controlled terminology, metadata and associated submission deliverables.

At Pierre Fabre Laboratories, we believe that our greatest asset is our people. We are committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law.

The information collected by this application is solely to determine suitability for employment, verify identify, and maintain employment statistics on applicants. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process. Thus, we commit to considering all applications equally, without fail.

Pierre Fabre Laboratories is the world’s second‑largest dermo‑cosmetics company and one of Europe’s leading pharmaceutical laboratories. Our Dermo‑cosmetics & Personal Care portfolio includes international brands such as Eau Thermale Avène, Ducray, Klorane, A‑Derma, René Furterer, Même Cosmetics, Darrow and Elgydium. The Medical Care activity covers 5 main therapeutic fields: oncology, dermatology, rare diseases, primary care and family health care. By choosing Pierre Fabre Laboratories, you will join a company where the human dimension is essential, where excellence and innovation are valued, within passionate teams united by common values, committed to pushing the boundaries of science to unite health and beauty for the benefit of all, because every time we care for a single person, we make the whole world better.