Senior Biometrics Transformation Lead - M/W (CDI)

INSTITUT DE RECHERCHE PIERRE FABRE SAS; Pechbusque; On-site; EUR 90,000 - 130,000; Full time

Job summary

Pierre Fabre Laboratories in France seeks a senior Transformation Lead to drive the biometrics operating model within the Data Science & Biometrics group. You will lead cross-functional transformation initiatives across statistics, programming, data management, and regulatory submissions, with a focus on modern standards and scalable processes.

The ideal candidate brings deep biometrics expertise in GxP environments, proficiency with SAS and R/Posit, and a track record of delivering governance,

Qualifications

• Senior statistician or statistical programmer with clinical development experience.
• Proven ability to lead projects, programs, or matrix teams.
• Strong transformation and governance skills across biometrics.
• Experience with SAS and R/Posit in a GxP environment.

Responsibilities

• Lead the Biometrics transformation roadmap and governance.
• Strengthen ownership of biometrics activities: statistics, programming, data management, submissions.
• Prioritize initiatives across portfolio and align teams.
• Define governance to improve study delivery from FIH to regulatory submissions.
• Internalize critical activities and ensure audit-ready processes.
• Promote standards like CDISC SDTM/ADaM and USDM, and automation.
• Establish RACI and collaboration between teams and CROs.
• Partner with QA to ensure GxP compliance.
• Facilitate senior workshops and decision forums.
• Define and monitor transformation KPIs.

Skills

Biometrics leadership

Statistical programming

Cross-functional collaboration

GxP compliance

Project governance

Education

Advanced statistics degree

Tools

SAS

R/Posit

CDISC SDTM/ADaM

USDM

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

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