Senior Preclinical Biostatistician H / F

Astek; Boulogne-Billancourt; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

A pharmaceutical company is seeking a Senior Preclinical Biostatistician to supervise statistical operations for clinical study projects. You will review protocols, manage timelines, and ensure adherence to quality standards while creating SAS statistical programs. The ideal candidate holds a Master's degree in statistics and has a minimum of 5 years of experience in clinical trials. Join a dynamic team and advance your skills in a supportive environment.

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

• Supervise statistical operations for clinical study projects.
• Review synopses and protocols for clinical trials.
• Monitor statistical study milestones and ensure quality standards.

Connaissances

SAS programming

Clinical trial statistics

Supervising teams

Regulatory standards knowledge

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.