Job Description

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

The Biometry Department at Pierre Fabre supports all drugs being developed by the company. The department encompasses Data Management, Programming, and Statistics, working cohesively to ensure the successful completion of both Randomized Controlled trials and Real-World evidence studies.

We are seeking a highly skilled and proactive Clinical Development Safety Statistics Expert to join our Biometry Department and the Biometry Leadership Team based in Toulouse (31, Oncopole) or Boulogne (92). This senior role is central to the safety oversight of clinical development programmes, with a particular emphasis on safety signal detection, benefit–risk evaluation, and regulatory compliance. The successful candidate will serve as the internal representative and process owner for clinical development safety, leading the harmonization and implementation of a company-wide safety signal detection framework, and working closely with the Head of Clinical Safety, Head of Clinical Development, Medical Directors, Data Managers, Statistical Programmers, and Statisticians.

Your role within a pioneering company in full expansion:

Key Responsibilities:

• Lead the design and implementation of safety signal detection processes for clinical development programmes by providing expert statistical support, ensuring early identification and evaluation of emerging safety risks.
• Provide statistical leadership specific to safety on the entire Pierre Fabre R&D portfolio, contributing to the conception of Controlled Trials and safety analysis plan.
• Coordinate periodic safety reviews at the programme level, synthesising data from AEs, SAEs, and other relevant sources, and supporting relevant R&D stakeholders in benefit–risk assessments.
• Lead the development and maintenance of safety analytics reporting tools in partnership with relevant R&D stakeholders.
• Serve as the primary point of contact in the Biometry Department for safety-related matters on the entire Pierre Fabre R&D portfolio, providing expert guidance to internal and external stakeholders.
• Collaborate with clinicians, medical writers, and regulatory partners to interpret safety data and communicate findings effectively.
• Oversee the selection and management of CROs and external vendors for safety analytics and signal detection activities.
• Program and/or validate statistical analyses using SAS or R software
• Ensure compliance with international regulatory guidelines (ICH, EMA, FDA) and internal procedures.
• Support the harmonization of safety processes across all clinical development programmes, including the deployment of pilot projects and the scaling of best practices.
• Represent Pierre Fabre in external clinical safety networks, working groups, and industry conferences to enhance the department’s visibility and reputation.

This position is compatible with teleworking up to 2 days a week according to company rules.

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, very attractive CE...

Your skills at the service of innovative projects:

• Advanced degree in Statistics (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 oncology clinical trials.

Mandatory Skills:

• Advanced expertise in safety signal detection, benefit–risk evaluation, and clinical trial methodology.
• Excellent knowledge of clinical safety processes and tools, including safety analytics and signal detection.
• Excellent knowledge of international scientific and regulatory guidelines (ICH, EMA, FDA, etc.).
• Excellent written and verbal communication skills in English
• Excellent communication and cooperation skills, with a rigorous and pragmatic approach.
• Creativity, proactivity, rigor, autonomy, and collaborative spirit.
• Strong ability to manage multiple projects simultaneously and maintain organization.
• Strong analytical skills with the ability to provide recommendations and propose/implement effective solutions.
• Proficiency in at least one of the following two statistical software: SAS or R

Optional Skills

• Knowledge of machine learning and AI techniques applied to safety analytics
• Familiarity with biomarker data and its applications in randomized controlled trials designs

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.