Early Phase Statistician - Clinical Development- M - F- CDI H/F Pierre Fabre

Votre mission

We 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).

Qui êtes-vous ?

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 Research Organization (CRO), with significant involvement in clinical trial development from the outset.

· Previous experience supporting early phase clinical trials, ideally including first-in-human, dose-escalation, dose-expansion, or proof-of-concept studies

· 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

· Knowledge of methodologies relevant to early clinical development, such as Bayesian methods, adaptive designs, dose-escalation methods, dose-response modelling, small-population methods

· Experience in quantitative decision-making process in early phase

· Ability to analyse and interpret complex and rapidly evolving clinical data.

· Strong knowledge of international scientific and regulatory guidelines (ICH, EMA, FDA, etc.).

· Excellent written and verbal communication skills in English

Strong experience in oncology clinical trials.

Optional Skills

• Familiarity with biomarker data.
• Experience with real world evidence (RWE) studies
• Familiarity with CDISC standards

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...

La première richesse des Laboratoires Pierre Fabre, sont les femmes et les hommes qui les composent disait M. Pierre Fabre.

Fiers de cet héritage, et convaincus que la diversité des parcours, des expériences et des identités renforce notre performance collective, nous nous engageons à promouvoir l'égalité des chances et à garantir un environnement inclusif pour tous. Dans le respect des lois en vigueur, toutes les candidatures sont étudiées avec la même attention, sans distinction d'origine, de sexe, d'âge, de situation de handicap, d'orientation sexuelle, d'identité de genre, de croyances ou de toute autre caractéristique protégée par la loi.