Early Phase Statistician

Il y a 2 jours

Boulogne, Pays de la Loire, France Pierre Fabre Pharmaceuticals, Inc. Temps plein 90 000 € - 120 000 €/an

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Early Phase Statistician
- Clinical Development
- 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## Early Phase Statistician
- Clinical Development
- M/F
- CDIApply: Haute Garonne (31): Hauts-de-Seine (92): Full time: Posted Today: JR114416# **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 missionWe are seeking a highly skilled and experienced Senior Early Phase Statistician – Clinical Development to join our Biometry Department (Boulogne or Toulouse) and provide statistical leadership for early clinical development programs, primarily from first-in-human studies through proof-of-concept development. The successful candidate will contribute to the design, execution, analysis, and interpretation of early phase clinical trials, with a particular focus on dose escalation, dose optimization, safety, preliminary evidence of clinical activity and quantitative decision making. The position requires a strong understanding of the statistical challenges associated with small populations, limited and evolving data, rapid decision-making, and adaptive development strategies.
The successful candidate will be agile and adaptable, capable of working in a matrix-organized environment where strong collaboration across Clinical Development, Pharmacology, Translational Medicine, Data Management, Statistical Programming, and Statistics is essential. Your role within a pioneering company in full expansion:
* Participate in the conception and design of early phase clinical trials, including first-in-human, dose-escalation, dose-expansion, and proof-of-concept studies.
* Provide expert statistical input into the definition of study objectives, endpoints, estimands, analysis populations, sample size considerations, decision criteria, and statistical sections of study protocols.
* Contribute to dose-escalation and dose-optimization strategies, including the evaluation and implementation of model-based, model-assisted, Bayesian, or adaptive approaches where appropriate.
* Collaborate with clinicians to the integration and interpretation of safety, pharmacokinetic, pharmacodynamic, biomarker, and preliminary efficacy data to support development decisions.
* Support the definition of quantitative decision criteria for dose selection, cohort expansion, proof of mechanism, proof of concept, and Go/No-Go decisions.
* 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.
* Draft and/or validate key study documents such as synopses, protocols, CRFs, data review plans, statistical analysis plans, statistical results, study reports and other study-level documents while ensuring timely deliverables.
* Program and/or validate statistical analyses using SAS and/or R
* 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.
* Contribute to the selection and evaluation of CROs, establishing clear requirements and evaluating proposals.
* 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 ?#Your skills at the service of innovative projects:*
* Advanced degree in Statistics (Master's Degree, ENSAI, ISUP, or PhD) or a related field.
· A minimum of 6 years of experience in the pharmaceutical industry or a Contract Researc

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