Senior Early Phase Statistician – Clinical Development- M/F in Boulogne-Billancourt

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).

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...

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