Statistics Methodology Expert -M/F- CDI

Pierre Fabre Pharmaceuticals, Inc.; Toulouse; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Telework up to 2 days/week

Profit sharing

Shareholding with matching

Health and provident insurance

Holidays RTT 16 + 25 personal

Job summary

Pierre Fabre Laboratories in Toulouse (Langlade, Oncopole) seeks a Statistics Methodology Expert to strengthen methodological excellence across drug development, RCTs and RWE studies. You will collaborate with statisticians and R&D functions to ensure robust statistical practices in a dynamic environment.

The role supports strategic scientific decisions, regulatory interactions and continuous improvement, with teleworking up to two days weekly.

Qualifications

• Advanced degree in Statistics, Biostatistics or a related field (Master's Degree or PhD).
• Proven ability to shape statistical strategy and defend complex methodological positions in regulatory or other high-impact scientific settings.
• Extensive experience in statistical methodology within the pharmaceutical industry or academia and supporting the design, analysis and interpretation of clinical trials.
• Experience working with cross-functional teams and contributing to interactions with regulatory or health-authorities.
• Experience in oncology or another therapeutic area relevant to Pierre Fabre would be an advantage.

Responsibilities

• Provide expert methodological support for clinical trials and Real-World Evidence studies across all phases of drug development.
• Advise statisticians on advanced, innovative or complex statistical methods.
• Support statistical strategy and methodological discussions during interactions with health authorities.
• Promote consistent and scientifically robust statistical approaches across studies and therapeutic areas.
• Translate new statistical methods into pragmatic guidance, tools, training and best practices.

Skills

Statistical leadership

Biostatistics

Clinical trials

Regulatory science

Oncology

Cross-functional teams

Education

Master's or PhD in Statistics

Tools

R

SAS

Job description

Statistics Methodology Expert -M/F- CDIWe use cookies to provide you with better personalization and advanced functionality when using our site. To continue and facilitate your navigation on the site, you can directly accept the use of cookies. Otherwise, you can customize the use of cookies.For more information click here# Careers## Statistics Methodology Expert -M/F- CDIApply: Haute Garonne (31): Full time: Posted Today: JR114405# ****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 **Statistics Methodology Expert** to join our Biometry Department located in Toulouse (Langlade, Oncopole).## ## Working closely with statisticians, other R&D functions and external scientific networks, the Statistics Methodology Expert will strengthen methodological excellence, scientific quality and regulatory robustness across the portfolio, acting as a recognised authority in advanced statistical methodology within and beyond Pierre Fabre.## ## ## **Your role within a pioneering company in full expansion:**## ## ## **Statistical Methodology and Scientific Support**## ## · Provide expert methodological support for clinical trials and Real-World Evidence studies across all phases of drug development.## · Advise statisticians on advanced, innovative or complex statistical methods.## · Support statistical strategy and methodological discussions during interactions with health authorities.## · Promote consistent and scientifically robust statistical approaches across studies and therapeutic areas.## · Assess the statistical robustness of investigator-initiated interventional and non-interventional studies as part of relevant governance processes.## · Provide methodological input into the evaluation of external opportunities and due diligence activities, as needed.## · Influence development strategies and major portfolio decisions by ensuring that statistical considerations are integrated early into scientific and clinical decision-making.## ## **Methodological Innovation and Continuous Improvement**## ## · Monitor advances in statistical science, regulatory thinking, technologies and industry practices.## · Define and champion Pierre Fabre’s methodological strategy in selected areas of advanced statistics, anticipating emerging scientific and regulatory expectations.## · Identify methodological areas for improvement and lead the evaluation and adoption of relevant approaches within Biometry.## · Translate new statistical methods into pragmatic guidance, tools, training and best practices.## · Contribute to the continuous improvement of statistical processes, quality, efficiency and reproducibility.## · Support the appropriate use of modern statistical computing environments, including R.## · Explore opportunities offered by automation, data science and AI to enhance statistical practice while maintaining scientific and regulatory rigour.## · Provide methodological oversight and expert review of key regulatory deliverables and submission packages.## **Capacity Building and Collaboration**## ## · Develop and deliver training in statistical methodology for Biometry and other Pierre Fabre collaborators.## · Provide coaching and technical mentorship to statisticians on complex methodological topics.## · Promote the exchange of methodological knowledge, lessons learned and good practices across teams.## · Coordinate cross-functional methodological initiatives through influence and scientific leadership.## **External Engagement and Scientific Visibility**## ## · Build and maintain a strong network of statistical experts in the pharmaceutical industry and academia.## · Represent Pierre Fabre in an influential capacity in international statistical working groups, professional societies and cross-industry initiatives.## · Shape external methodological thinking and regulatory science through working groups, scientific committees, consultation activities and interactions with health authorities.## · Participate in scientific committees for leading statistical and pharmaceutical conferences.## · Support and encourage statisticians in presenting their work through conference presentations and posters.## · Lead or contribute to publications in peer-reviewed statistical and scientific journals.## · Strengthen the visibility of Pierre Fabre’s Biometry Department and its methodological expertise.## # # ****Who you are ?****### **Your skills at the service of innovative projects:** · Advanced degree in Statistics, Biostatistics or a related field (Master's Degree or PhD). Established track record of methodological leadership and scientific influence within the pharmaceutical industry, regulatory science or academia.· Proven ability to shape statistical strategy and defend complex methodological positions in regulatory or other high-impact scientific settings.· Extensive experience in statistical methodology within the pharmaceutical industry or academia and supporting the design, analysis and interpretation of clinical trials.· Experience working with cross-functional teams and contributing to interactions with regulatory or health-authorities.· Experience in oncology or another therapeutic area relevant to Pierre Fabre would be an advantage. 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...*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.