Senior Biometrics Transformation Lead - M/W (CDI)

Pierre Fabre; Toulouse; Hybrid; EUR 120,000 - 180,000; Full time

Job summary

Pierre Fabre is seeking a senior Transformation lead to steer the Biometrics transformation across data management, statistics, programming, and regulatory submissions in Toulouse.

You will partner with Data Science & Biometrics, Clinical Development, Medical Writing, QA, IT, and external partners to implement a scalable, inspection-ready operating model, promote CDISC SDTM/ADaM, SAS and R/Posit, and foster automation and GenAI within a GxP framework.

Qualifications

• Advanced degree (MSc/PhD) in Statistics, Biostatistics, or Statistical Programming.
• 10+ years in pharmaceutical/biotech R&D with leadership in biometrics.
• Strong experience in CDISC SDTM/ADaM, SAS, and R/Posit.
• Proven program/transformational leadership in complex R&D environments.

Responsibilities

• Lead Biometrics transformation roadmap and operating model changes.
• Oversee statistical programming, TFL delivery, data management, and submissions.
• Build governance, accountability, and KPIs across biometrics functions.
• Collaborate with cross-functional teams and CROs for regulatory deliverables.

Skills

Leadership

Statistical Programming

Clinical Development

CDISC SDTM/ADaM

SAS

R/Posit

GxP

Project Management

Communication

Education

MSc or PhD in Statistics/Biostatistics/Statistical Programming

Tools

SAS

R/Posit

CDISC tools

Job description

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...# Qui êtes-vous ?**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 Fabre's 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.