Pierre Fabre is the 2nd largest dermo-cosmetics 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 including Pierre Fabre Oncologie Pierre Fabre Dermatologie Eau Thermale Avène Klorane Ducray René Furterer A-Derma Naturactive Pierre Fabre Oral Care.

Established in the Occitanie region since its creation and manufacturing over 95% of its products in France the Group employs some 10000 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 Groups corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the Excellence level.

Pierre Fabre is recognized as one of the Worlds Best Employers 2021 by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide.

Your mission

We are currently seeking a highly skilled and experienced Lead Statistical Programmer to join our Biometry Department part of the Data Science & Biometry Department based in Toulouse (31 Langlade Oncopole) or Boulogne (92).

This position requires a strong expertise in the application of programming within the context of randomized controlled trials (RCTs).

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. Whilst an excellent track record in Randomized Controlled Trials is a must the successful candidate will also contribute to Real Worl Evidence (RWE) studies.

Your role within a pioneering company in full expansion:

Key Responsibilities

• Participate in the design and execution of RCTs and RWE studies ensuring high-quality programming support.
• Develop and validate programs for data analysis reporting and visualization in accordance with regulatory guidelines and standards (e.g. ICH EMA FDA PMDA).
• Collaborate with statisticians data managers and other stakeholders to ensure accurate and efficient data processing and analysis.
• Assist in the selection and evaluation of subcontractors establishing clear requirements and evaluating proposals.
• Contribute to the preparation of regulatory documents and scientific publications by providing programming support and expertise.
• Follow all industry standards including ensuring that all biometry-related documentation is included in the electronic Trial Master File (eTMF).

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 (Masters Degree ENSAI ISUP or PhD) or a related field.
• A minimum of 6 years of experience in the pharmaceutical industry or a Contract Research Organization (CRO) with hands-on experience in RCTs and RWE studies.
• Programming in CDISC (SDTM & ADaM) and writing associated documentation (Define ADRG...)

Mandatory Skills

• Proficiency in SAS and R programming languages
• Extensive experience in Randomized Controlled Trials (RCTs)
• Strong knowledge in CDISC (SDTM & ADaM) and associated documents (Define ADRG ...)
• Strong knowledge of international scientific and regulatory recommendations (e.g. ICH EMA FDA)
• Ability to collaborate effectively with statisticians data managers and other stakeholders
• 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 studies simultaneously and maintain organization.
  

Optional Skills

• Experience with other statistical programming languages (e.g. Python SQL)
• Knowledge of Real-World Evidence (RWE) studies
• Experience in EMA FDA or PMDA submissions
• Experience in oncology clinical trials

Application Process

Interested candidates should submit their resume and a cover letter detailing their experience and qualifications for this position.

The hiring manager is Romain Raymond Programming & Biometry Platform 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 are convinced that diversity is a source of fulfillment social balance and complementarity for our employees which is why our offers are open to all without restriction.