Senior Biometrics Transformation Lead MW (CDI)

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 10000 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.

We are seeking a senior and highly experienced Transformation lead to join our Data Science and Biometrics (DS&B) group and lead the transformation of our biometrics operating model.

At Pierre Fabre Group we are committed to advancing Pharma R&D to deliver innovative treatments for patients. Our strategic focus areas include Oncology Dermatology and Rare Diseases. Our internal R&D pipeline complemented by selected external opportunities will shape the future of Pierre Fabre Pharma.

The position is a strategic role for an expert statistician and/or statistical programmer with strong clinical development experience and leading projects programs teams or matrix organizations. The successful candidate will combine deep technical credibility in biometrics with proven ability to drive cross-functional transformation improve ways of working strengthen internal ownership and increase control over critical study and submission deliverables.

You will work closely with Data Science & Biometrics Clinical Development Medical Writing Clinical Operations Regulatory Affairs Quality Assurance R&D IT and external partners to implement a scalable and inspection-ready operating model across clinical data management statistics statistical programming vendor oversight and regulatory submission activities.

The role will also contribute to our ambition to modernize biometrics through stronger adoption of clinical data standards including CDISC SDTM/ADaM and USDM modern statistical computing environments such as SAS and R/Posit and fit-for-purpose use of automation and GenAI in a GxP-compliant environment.

Your role within a pioneering company in full expansion:

Key Responsibilities

• Lead the execution of the Biometrics transformation roadmap translating strategic priorities into concrete operating model changes governance processes and measurable outcomes.
• Strengthen internal ownership and oversight of critical biometrics activities including statistical strategy statistical programming TFL delivery data management quality control and submission-related outputs.
• Prioritize and sequence competing initiatives across the biometrics transformation portfolio helping teams arbitrate trade-offs transparently and align on what comes first.
• Define and implement pragmatic governance mechanisms to improve transparency accountability and predictability of study delivery from FIH through registrational studies and regulatory submissions.
• Support the gradual internalization or reinforced oversight of selected high-value activities in particular statistical programming TFL delivery data flow and critical submission-related deliverables.
• Champion adoption of clinical data standards (CDISC SDTM/ADaM USDM) modern statistical computing environments and automation/GenAI opportunities across the biometrics data flow in a GxP-compliant manner and pragmatic way.
• Establish robust RACI models and ways of working between internal teams CROs Clinical Development Medical Writing Clinical Operations Regulatory Affairs Quality Assurance and R&D IT.
• Partner with Quality Assurance to ensure that transformed processes are compliant documented audit-ready and aligned with GxP expectations.
• Facilitate senior-level workshops governance meetings and decision forums to align stakeholders resolve bottlenecks and accelerate adoption of new ways of working.
• Define and monitor transformation KPIs including delivery predictability quality indicators vendor performance internal oversight levels process cycle times and adoption of new governance models.
• Provide concise executive-ready updates recommendations risk assessments and decision support to DS&B and R&D leadership.
• Drive change in Biometrics practices in data management statistical programming and statistics and ensure adoption of news ways of working.

This position is based in Toulouse with flexible commuting options within France/Europe.

We offer an attractive remuneration/benefits package: Incentives profit-sharing Pierre Fabre shareholding with matching contribution health and provident insurance 16 days of holidays (RTT) in addition to 25 days of personal holidays public transport participation...

Your skills at the service of innovative projects:

• Hold an advanced degree preferably MSc or PhD in Statistics Biostatistics or Statistical Programming.
• Have significant senior-level experience in pharmaceutical or biotech R&D (10 years) with a strong track record as lead statistician statistical programming lead biometrics team lead or equivalent role.
• Have demonstrated leadership experience in both FIH/early clinical development studies and pivotal studies including interactions with clinical teams CROs and regulatory stakeholders.
• Bring deep understanding of clinical trial design statistical analysis plan TFL production data standards data flow clinical reporting and regulatory submission requirements.
• Have proven experience overseeing or leading statistical programming activities either directly or through CRO/vendor models with strong ability to challenge timelines assumptions quality and delivery risks.
• Have a strong understanding of outsourced biometrics operating models and demonstrated ability to improve CRO governance vendor oversight and internal control of critical deliverables.
• Are familiar with CDISC standards including SDTM and ADaM and modern statistical computing environments including SAS and R/Posit.
• Understand the opportunities and constraints of automation and GenAI in clinical development including the need for fit-for-purpose validated and GxP-compliant implementation.
• Bring demonstrated consulting transformation operational excellence or program management experience in a complex R&D environment.
• Are fluent in English and French with the ability to work effectively in an international and cross-functional environment.
• Experience in one of Pierre Fabres strategic Therapeutic Areas (oncology dermatology rare diseases or other complex clinical development settings) is a plus.

• Prior consulting experience internal transformation leadership or formal training in project/program management lean/process improvement or change management.

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 companys 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.