Late Phase Statistician - Clinical Development

Pierre Fabre; Toulouse; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Télétravail partiel

Avantages attractifs

Job summary

Laboratoires Pierre Fabre recherche un Senior Statistician pour diriger les activités statistiques des programmes de développement clinique en phase avancée (IIb/III). Vous travaillerez au sein du Département Biométrie et assurerez la conception, l analysis et l interprétation des essais avec une interaction régulière avec les autorités réglementaires.

Le candidat idéal maîtrise les estimands, les stratégies de multiplicité et les analyses intégrées, et peut programmer avec SAS et R.

Qualifications

• Diplôme avancé en statistiques requis (Master, ENSAI, ISUP ou PhD).
• Expérience minimale de 6 ans en industrie pharmaceutique/CRO.
• Conception et analyse d essai clinique de phase IIb/III.
• Contributions aux soumissions réglementaires et analyses intégrées.

Responsibilities

• Concevoir et superviser des essais de phase IIb/III et la détermination de la taille d étude.
• Diriger les analyses statistiques et les interprétations des résultats.
• Rédiger et valider les documents statistiques et les plans d analysis.
• Collaborer avec les cliniciens, les rédacteurs médicaux et les autorités réglementaires.

Skills

Advanced statistics

Clinical trial design

SAS

R

Regulatory submissions

Education

Master's degree or PhD in Statistics

Tools

SAS

R

Job description

Late Phase Statistician - Clinical DevelopmentNous utilisons des cookies pour vous offrir une meilleure personnalisation et des fonctionnalités avancées lorsque vous utilisez notre site. Pour poursuivre et faciliter votre navigation sur le site, vous pouvez directement accepter l'utilisation des cookies. Sinon, vous pouvez personnaliser l'utilisation des cookies. Pour en savoir plus sur le traitement de données personnelles, consultez notre politique de confidentialité en cliquant ci-dessous : Politique de confidentialité.# Carrières## Late Phase Statistician - Clinical DevelopmentPostuler: Haute Garonne (31): Hauts-de-Seine (92): Temps plein: Offre publiée hier: JR114437# Qui sommes-nous ?Nous sommes les Laboratoires Pierre Fabre, leader mondial qui allie expertise pharmaceutique et dermo-cosmétique pour accompagner les consommateurs et les patients à chaque étape de leur parcours de soins. Notre portefeuille compte plusieurs franchises médicales et marques internationales dont Eau thermale Avène, Ducray, A-Derma, Klorane, René Furterer et Pierre Fabre Oral Care. En nous rejoignant, vous intégrez une entreprise riche de sens, où la dimension humaine est essentielle. Vous devenez acteur du \"We Care Movement\", un mouvement qui valorise l'excellence et l'innovation au sein d'équipes passionnées. Ensemble, nous repoussons les limites de la science pour unir santé et beauté au bénéfice de tous, car à chaque fois que nous prenons soin d’une seule personne, nous rendons le monde meilleur. Présents dans 120 pays et une équipe de plus de 10 000 collaborateurs, nous sommes fiers de créer un impact scientifique et humain, aujourd'hui et demain! Si prendre soin est au cœur de vos valeurs, rejoignez les Laboratoires Pierre Fabre et devenez un acteur clé du \"We Care Movement\".# Votre missionThe Biometry Department at Pierre Fabre supports all drugs 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 Real-World evidence studies. We are seeking a highly skilled and experienced Senior Statistician (6+ years of experience in a similar position) to join our Biometry Department and provide statistical leadership for late-stage clinical development programs, primarily phase IIb and phase III randomized controlled trials and activities supporting regulatory submissions. The successful candidate will interact with Health Authorities and will play a central role in the design, execution, analysis, interpretation, and reporting of confirmatory clinical trials intended to provide robust evidence of efficacy and safety. The position requires strong expertise in estimands, confirmatory testing strategies, missing data, sensitivity analyses, multiplicity control, safety and efficacy integrated analyses, and regulatory submissions. The successful candidate will be agile and adaptable, capable of working in a matrix-organized environment where collaboration across Data Management, Programming, and Statistics is essential. **Your role within a pioneering company in full expansion:**Key Responsibilities * Participate in the conception and design of phase IIb and phase III randomized controlled trials, providing expert statistical support for study design, sample size determination, randomization, endpoint selection, estimand definition, and confirmatory testing strategies.* Lead the statistical definition and justification of primary and key secondary endpoints, analysis populations, intercurrent event strategies, missing data approaches, sensitivity analyses, and multiplicity adjustments**.*** Contribute to the design and statistical oversight of interim analyses, Independent Data Monitoring Committees, adaptive confirmatory designs, and event-driven analyses, where applicable.* 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* Collaborate with clinicians to interpret results, develop key messages, and communicate findings to clinical and regulatory partners.* Contribute to the development of submission strategies and statistical content for regulatory dossiers submitted to agencies such as EMA, FDA, and PMDA* Coordinate the production of integrated summaries and pooled analyses of efficacy and safety, ensuring consistency across studies, endpoints, and populations* Support regulatory inspections, submission readiness activities, and the traceability of statistical decisions and deliverables* 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.* Strong experience in the design, analysis, and reporting of phase IIb and/or phase III randomized controlled trials.* Experience contributing to regulatory submissions, responses to regulatory authorities, or integrated efficacy and safety analyses is highly desirable.* Strong experience in oncology clinical trials. Mandatory Skills * Advanced statistical analysis skills* Proficiency in at least one of the following two statistical software: SAS or R* Strong expertise in pivotal Phase III development, registration activities and regulatory strategy* Strong knowledge of confirmatory clinical trial methodology, including estimands, multiplicity control, missing data methods, sensitivity analyses, interim analyses, and interpretation of efficacy and safety results* Experience supporting global regulatory submissions and health-authority interactions.* Experience with integrated summaries of efficacy and safety.* Experience supporting Independent Data Monitoring Committees or interim analyses.* Strong knowledge of international scientific and regulatory guidelines (ICH, EMA, FDA, etc.).* Excellent written and verbal communication skills in English Optional Skills * Familiarity with adaptive confirmatory designs* Familiarity with CDISC standards and submission-ready clinical data packages* Experience with real world evidence (RWE) studies* Familiarity with biomarker data and its applications in randomized controlled trials designs Terms of Employment * Full-time position.* Work location: On-site at either Toulouse Langlade or Boulogne, with the possibility of working from home up to 2 days per week.* 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... Application Process Interested candidates should submit their resume and a cover letter detailing their experience and qualifications for this position. 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.*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.