Senior Early Phase Statistician – Clinical Development- M/F

Laboratoires Pierre Fabre; Boulogne-Billancourt; Híbrido; EUR 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Incentives

Profit-sharing

Shareholding with matching

Health insurance

Provident insurance

16 RTT days + 25 personal days

Public transport participation

Descripción de la vacante

Laboratoires Pierre Fabre in Boulogne-Billancourt seeks a Senior Early Phase Statistician to provide statistical leadership for early clinical development programs, from first-in-human studies through proof-of-concept.

You will design and analyze early phase trials, advise on estimands and decision criteria, apply model-based or adaptive methods, and collaborate with clinical, pharmacology and writing teams to support regulatory submissions.

Formación

• Minimum 6 years’ experience in pharma/ CRO on early phase clinical development.
• Experience with first-in-human, dose-escalation, dose-expansion, or proof-of-concept studies
• Strong understanding of trial design, estimands and adaptive methods
• Ability to generate regulatory-ready statistical documents and outputs
• Excellent written and verbal English communication skills
• Oncology trial experience is a plus

Responsabilidades

• Conceive and design early phase clinical trials (FIH, dose-escalation, dose-expansion, proof-of-concept).
• Provide statistical input on objectives, endpoints, estimands, analysis populations and sample size.
• Lead model-based, model-assisted, Bayesian or adaptive approaches where appropriate.
• Collaborate with clinicians to integrate safety, PK/PD, biomarkers, and preliminary efficacy data.
• Define quantitative decision criteria for dose selection and Go/No-Go decisions.
• Draft or validate key study documents (synopses, protocols, CRFs, SAPs, reports).
• Conduct analyses with SAS and/or R; support regulatory responses and scientific publications.

Conocimientos

Advanced statistical analysis

English communication

Cross-functional collaboration

Educación

Master's Degree in Statistics

PhD (related field)

Herramientas

SAS

R

Descripción del empleo

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...