Senior Preclinical Biostatistician H / F

Astek; Paris; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

A leading CRO company in France is looking for a Senior Preclinical Biostatistician to supervise statistical operations for clinical trials in the pharmaceutical sector. You will engage with internal teams and external providers to ensure timely and accurate project deliverables. The ideal candidate has a Master's degree in statistics and at least 5 years of related experience, specializing in SAS programming and methodologies for late-phase studies. Join a dynamic and motivated team ready to welcome you.

Qualifications

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

Responsabilités

• Supervising statistical operations within clinical study projects.
• Reviewing statistical deliverables from providers.
• Ensuring timely delivery of results and datasets.
• Creating and validating SAS statistical programs.

Connaissances

SAS programming

Statistics applied to clinical trials

Supervising statistical teams

Understanding of FDA/EMA/ICH standards

Formation

Master's degree in statistics / biometrics (Bac +5 minimum)

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.