Senior biostatisticien

JR France; Asnières-sur-Seine; Sur place; EUR 50 000 - 75 000; Plein temps

Résumé du poste

Une entreprise reconnue dans le domaine de la recherche clinique cherche un statisticien senior à Asnières-sur-Seine. Ce poste implique la réalisation d'activités statistiques dans le cadre d'études cliniques, avec un fort accent sur les exigences réglementaires et la collaboration internationale. Les candidats doivent avoir une solide formation en statistiques et une expérience dans l'industrie pharmaceutique.

Qualifications

• Formation supérieure en statistiques nécessaire.
• Au moins 6 ans d'expérience dans l'industrie pharmaceutique/CRO.
• Bilingue en français et anglais.

Responsabilités

• Conduire des activités statistiques dans la conception d'études.
• Superviser les activités statistiques externalisées.
• Être le point de contact pour toutes les questions liées aux statistiques.

Connaissances

SAS

R

Connaissance des lignes directrices scientifiques internationales

Fluente en anglais

Bilingue en français

Formation

Master en statistiques ou PhD

Description du poste

Senior biostatistician, Asnières-sur-Seine

Asnières-sur-Seine, France

Are you passionate about Life Sciences and Clinical Research? Do you want to evolve in a dynamic and collaborative international environment where your expertise has a direct impact on the lives of millions of people? We are seeking a senior biostatistician to bring their expertise to statistical activities and ensure the smooth running of projects.

1. Conduct statistical activities in study design: sample size calculation, design choices, evaluation criteria, estimand definitions, etc.
2. Be the point of contact for all topics related to statistics and participate in project/study meetings.
3. Participate in the selection of subcontractors by establishing specifications and evaluating proposals.
4. Draft and/or review the synopsis, protocol, statistical analysis plan, randomization specifications, and other study documentation.
5. Supervise outsourced statistical activities to CROs and ensure compliance with cost, timeline, and data quality requirements.
6. Verify the presence of all statistical documentation in the Trial Master File (TMF).

Requirements:

1. Higher education in statistics (ENSAI, ISUP, Master's in statistics, or PhD).
2. At least 6 years of experience in the pharmaceutical/CRO industry in a similar role, involved from early clinical development stages (oncology).
3. Proficiency in SAS and R software.
4. Solid knowledge of international scientific and regulatory guidelines (ICH, EMA, FDA, ...).
5. Fluent in English (reading, writing, speaking) and bilingual in French.

About us:

We are one of the world leaders in CROs, with a commitment, expertise, and flexibility necessary for conducting clinical studies. We work with pharmaceutical, biotechnological, cosmetic companies, and more, providing innovative and adaptable solutions. Operating in 10 countries across 3 continents, we have over 1000 talented professionals dedicated to advancing clinical research. Join us to work on cutting-edge projects that truly impact millions of lives. We prioritize gender parity in our development strategy.