Senior Preclinical Biostatistician H / F

Astek; Vanves; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading CRO company is seeking a Senior Preclinical Biostatistician in Île-de-France to oversee statistical operations in clinical studies. The role requires a Master's degree in statistics/biometrics and at least 5 years of experience in clinical trials and SAS programming. Responsibilities include supervising teams, reviewing study protocols, and ensuring timely delivery of quality results. Join a dynamic team to contribute to impactful healthcare solutions.

Qualifications

• Minimum 5 years of experience in statistics applied to clinical trials and SAS programming.
• Experience supervising service providers or statistical teams.
• Good expertise in methodologies related to late-phase studies / clinical development.

Responsabilités

• Supervise statistical operations within clinical study projects.
• Review synopses and protocols including sample size and study design.
• Ensure timely delivery of statistical results and datasets.

Connaissances

Statistical analysis

SAS programming

Team supervision

Clinical trial methodology

Formation

Master's degree in statistics / biometrics

Description du poste

Alsinova, the Astek Group subsidiary offering a complete CRO solution, is recruiting a Senior Preclinical Biostatistician for a project in the pharmaceutical sector.

Your mission (should you decide to accept it) :

Reporting to our partner's ClinOps Biometrics department, and working with internal teams and service providers, you will be responsible for supervising statistical operations within the framework of clinical study projects sponsored by our partner (primary and secondary data).

Your daily activities will be :

Under the supervision of the Statistical Manager for a dedicated therapeutic area, you will be responsible for :

• Reviewing synopses and protocols (sample size, design, primary endpoint, methodology)
• Supervising statistical deliverables from providers (analysis plans, TFLs, interim analyses, etc.)
• Monitoring statistical study milestones
• Managing progress via provider dashboards
• Ensuring timely delivery of results and datasets, in accordance with quality standards (quality control / SAS programming)
• Reviewing clinical study reports and external communications
• Being responsible for completing the eTMF file
• Creating SAS statistical programs and validating the codes
• Monitoring and applying regulatory standards (FDA, EMA, ICH, etc.)

Your future team :

• You will join a young, enthusiast, motivated and dynamic team with strong ambitions, and ready to welcome you.
• You'll be trained by a highly knowledgeable coach who will give you all his success secrets.

You :

• Master's degree in statistics / biometrics (Bac +5 minimum).
• Minimum 5 years of experience in statistics applied to clinical trials and SAS programming.
• Experience supervising service providers or statistical teams.
• Good expertise of methodologies related to late-phase studies / clinical development.