Lead Statistician Real World Evidence MFD
Lead Statistician Real World Evidence MFD
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Job Description
Who we are
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 including Pierre Fabre Oncologie Pierre Fabre Dermatologie Eau Thermale Avne Klorane Ducray Ren Furterer ADerma 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 governmentrecognized publicinterest 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
Pierre Fabre Laboratories are hiring a highly skilled and experienced Lead Statistician 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 a strong expertise in the application of statistics within the context of RealWorld Evidence studies. The successful candidate will be agile and adaptable capable of working in a matrixorganized environment where collaboration across Data Management Programming and Statistics is essential. Whilst an excellent track record in RWE is a must the successful candidate will also contribute to clinical trials including randomized controlled trials (RCTs).
The Biometry Department at Pierre Fabre supports all 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 RealWorld evidence studies.
Pierre Fabre is a global pharmaceutical company dedicated to the research development and commercialization of innovative . Our Biometry Department is integral to our success providing comprehensive support for all drug development initiatives including Randomized Controlled Trials (RCTs) and RealWorld Evidence (RWE) studies.
Key Responsibilities:
- Participate in the conception and design of RealWorld Evidence studies providing expert statistical support including study design sample size determination definition of study objectives and evaluation criteria writing the statistical section of the protocol and development of the statistical analysis plan.
- Act as the primary point of contact internally and externally for all statistical aspects of assigned projects and studies attending project/study meetings and offering statistical guidance.
- Contribute to the selection and evaluation of subcontractors establishing clear requirements and evaluating proposals.
- Draft and/or validate key study documents such as synopses protocols CRFs data review plans statistical analysis plans statistical results study reports and other studylevel documents while ensuring timely deliverables.
- Program and/or validate statistical analyses using SAS software.
- Collaborate with project team and clinicians to interpret results develop key messages and contribute to scientific publications
- Work with clinicians and medical writers to communicate findings to clinical and regulatory partners prepare Response to Questions from regulatory agencies (EMA / FDA / PMDA / and prepare summaries of results for regulatory documents
- Contribute to the RWE strategy for the submission dossier to FDA and EMA.
- Oversee the review of statistical documents within the team and supervise operational activities outsourced to CROs ensuring adherence to cost timeline and data quality requirements.
- Follow all industry standards including ensuring that all statistical related documentation is included in the electronic Trial Master File (eTMF)..
Who you are
Qualifications / Experience
- 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 significant involvement in Real World Evidence studies from the outset.
Mandatory Skills
- Advanced statistical analysis skills
- Proficiency in SAS software
- Strong understanding of realworld evidence studies design and methodology
- Familiarity with the specific methodologies and regulations associated with RealWorld evidence studies.
- Comprehensive understanding of both primary data collection and secondary data reutilization in studies.
- Familiarity with regulatory guidelines (ICH EMA FDA NICE ENcEPP)
- 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 interventional studies
- Knowledge of CDISC standards
Terms of Employment
- Fulltime position.
- Work location: Onsite at either Toulouse Langlade or Boulogne with the possibility of working from home up to 2 days per week.
Application Process
Interested candidates should submit their resume and a cover letter detailing their experience and qualifications for this position.
The hiring manager is Benot 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 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.
Employment Type
Full-Time
