Lead Statistician Real World Evidence MFD

Pierre Fabre; Toulouse; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading pharmaceutical company is seeking a skilled Lead Statistician for Real World Evidence studies. This role involves statistical support for RWE and clinical trials, requiring collaboration across various departments. The ideal candidate has extensive experience in RWE studies and advanced statistical skills, particularly in SAS. The position allows for some remote work, making it a flexible opportunity in a dynamic environment.

Qualifications

• At least 6 years of experience in the pharmaceutical industry or a CRO.
• Significant involvement in RWE studies from inception.

Responsabilités

• Participate in the conception and design of RWE studies.
• Serve as the primary contact for all statistical aspects of assigned projects.
• Draft and validate key study documents such as protocols and analysis plans.

Connaissances

Advanced statistical analysis skills

Proficiency in SAS software

Excellent written and verbal communication skills in English

Strong collaboration skills

Formation

Advanced degree in Statistics

Outils

SAS

Description du poste

Pierre Fabre is the 2nd largest dermocosmetics laboratory in the world, the 2nd largest private French pharmaceutical group, and the market leader in France for products sold over the counter in pharmacies.

Its portfolio includes several medical franchises and international brands, such as Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, Ren, Fureter, A-Derma, Naturactive, and Pierre Fabre Oral Care.

Established in the Occitanie region since its inception, with over 95% of its products manufactured in France, the Group employs approximately 10,000 people worldwide. Its products are distributed in about 130 countries. 86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation, a government-recognized public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan.

In 2019, Ecocert Environment assessed the Group's corporate social and environmental responsibility approach according to the ISO 26000 standard and awarded it the Excellence level.

Pierre Fabre was recognized as one of the World's Best Employers in 2021 by Forbes, ranking in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide.

Your mission

Pierre Fabre Laboratories is hiring a highly skilled and experienced Lead Statistician for Real World Evidence (RWE) to join the Biometry Department, part of the Data Science & Biometry Department, based in Toulouse (Oncople) or Boulogne.

This position requires strong expertise in statistics within the context of RWE studies. The successful candidate will be agile and adaptable, capable of working in a matrix-organized environment where collaboration across Data Management, Programming, and Statistics is essential. While extensive experience in RWE is required, the candidate will also contribute to clinical trials, including randomized controlled trials (RCTs).

The Biometry Department supports all development projects by the company, encompassing Data Management, Programming, and Statistics, working cohesively to ensure the successful completion of both RCTs and RWE studies.

Pierre Fabre is a global pharmaceutical company dedicated to research, development, and commercialization of innovative products. Our Biometry Department plays a vital role in supporting drug development initiatives, including RCTs and RWE studies.

Key Responsibilities

• Participate in the conception and design of RWE studies, providing expert statistical support, including study design, sample size determination, objectives, evaluation criteria, protocol writing, and analysis plan development.
• Serve as the primary contact for all statistical aspects of assigned projects and studies, attending meetings and providing statistical guidance.
• Contribute to the selection and evaluation of subcontractors, establishing requirements, and evaluating proposals.
• Draft and validate key study documents such as protocols, CRFs, analysis plans, and study reports, ensuring timely delivery.
• Program and validate statistical analyses using SAS software.
• Collaborate with project teams and clinicians to interpret results, develop key messages, and contribute to scientific publications.
• Work with clinicians and medical writers to communicate findings to regulatory agencies (EMA, FDA, PMDA) and prepare summaries and responses for regulatory submissions.
• Contribute to RWE strategy for submission dossiers to FDA and EMA.
• Oversee the review of statistical documents within the team and supervise operational activities outsourced to CROs, ensuring adherence to timelines, budgets, and data quality standards.
• Ensure compliance with industry standards, including proper documentation in the electronic Trial Master File (eTMF).

Who you are

Qualifications / Experience

• Advanced degree in Statistics (Master's, ENSAI, ISUP, or PhD) or a related field.
• At least 6 years of experience in the pharmaceutical industry or a CRO, with significant involvement in RWE studies from inception.

Mandatory Skills

• Advanced statistical analysis skills
• Proficiency in SAS software
• Strong understanding of RWE study design and methodology
• Knowledge of methodologies and regulations related to RWE studies
• Understanding of primary data collection and secondary data reuse
• Familiarity with regulatory guidelines (ICH, EMA, FDA, NICE, ENCePP)
• Excellent written and verbal communication skills in English
• Strong collaboration skills, rigorous, pragmatic, proactive, and autonomous
• Ability to manage multiple studies simultaneously and stay organized

Optional Skills

• Experience with interventional studies
• Knowledge of CDISC standards

Terms of Employment

• Location: Onsite at Toulouse Langlade or Boulogne, with up to 2 days per week remote work possible.

Application Process

Interested candidates should submit their resume and cover letter detailing their experience and qualifications.

The hiring manager is Benoît Sansas, Biometry Manager.

The Head of the Biometry Department is Guillaume Desachy.

We look forward to welcoming a new member to our dedicated and innovative team at Pierre Fabre.

We believe diversity fosters fulfillment, social balance, and complementarity among our employees, and our offers are open to all without restriction.

Key Skills

SAS, R, Regression Analysis, Survival Analysis, Clinical Trials, Data Mining, Statistics, Data Analysis Skills, Statistical Software

Employment Type: Full-Time

Experience: 6+ years

Vacancy: 1