Lead Statistician - Clinical Trials MFD
Lead Statistician - Clinical Trials 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
The Biometry Department part of the Data Science & 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.
We are seeking a highly skilled and experienced Lead Statistician in Clinical Trials to join our Biometry Department. This position requires a strong expertise in the application of statistics within the context of clinical trials including Randomized Controlled Trials (RCTs).
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 Randomized Controlled Trials is a must the successful candidate will also contribute to Real World Evidence (RWE) studies.
Key Responsibilities:
- Participate in the conception and design of Randomized Controlled Trials providing expert statistical support including study design sample size determination definition of study objectives and Estimates 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 clinicians to interpret results develop key messages and communicate findings to clinical and regulatory partners.
- Work with clinicians and medical writers to prepare Response to Questions from regulatory agencies (EMA / FDA / PMDA / summaries of results for regulatory documents and scientific articles.
- 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.
- Participate in the strategy of submission dossier to FDA and EMA.
- Coordinate production of Safety and Efficacy integrated pool and related statistical analyses
- Follow all industry standards including ensuring that all statistical related documentation is included in the electronic Trial Master File (eTMF).
Who you are
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 clinical trial development from the outset.
- Strong experience in oncology clinical trials.
- Advanced statistical analysis skills
- Proficiency in at least one of the following two statistical software: SAS or R
- Strong understanding of clinical trial design and methodology with substantial knowledge in at least of the following: Bayesian Adaptive Designs Basket / Umbrella / Platform Trial MultipleTesting Adjustment Small Populations Individualized Treatment Effects
- Strong 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 studies simultaneously and maintain organization.
Optional Skills
- Experience with real world evidence (RWE) studies
- Familiarity with CDISC standards
- Familiarity with machine learning techniques
- Familiarity with biomarker data and its applications in randomized controlled trials designs
Application Process
Interested candidates should submit their resume and a cover letter detailing their experience and qualifications for this position.
The hiring manager is Florence Carrre 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.
Le Dpartement Biomtrie qui fait partie du Dpartement Data Science & Biomtrie) de Pierre Fabre recrute en CDI Toulouse (site Langlade) ou Boulogne un(e) Lead Statistician pour les essais cliniques. Vous participerez en autres au design des tudes cliniques contrls randomiss et la soumission des dossiers aux autorits de sant tout en supervisant les CROs de votre primtre.
Une exprience de 6 ans minimum en industrie pharmaceutique et en CRO avec une implication significative dans le dveloppement des tudes cliniques interventionnelles en Oncologie et la supervision de CRO sont ncessaires pour la tenue du poste.
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
