Senior RWE Statistician — Biostatistics Lead

Excelya Group; Boulogne-Billancourt; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Excelya is seeking an experienced statistician to join a dedicated Statistics team overseeing Real-World Evidence and secondary use data studies. You will provide statistical leadership, review study protocols and SAPs, and supervise external providers to ensure timely, high-quality outputs that meet regulatory requirements.

The role involves collaboration with Biometry, Clinical Operations, Medical teams, and external partners, with a focus on data integrity and eTMF documentation.

Qualifikationen

• Master’s degree in a scientific discipline related to statistics or biostatistics.
• Significant experience in statistics and statistical programming in pharma/biotech/healthcare.
• Proven ability to lead statistical teams and manage external providers.

Aufgaben

• Review study synopses and protocols, including sample size calculations and design.
• Oversee SAPs, TFLs, and interim analyses from external service providers.
• Monitor milestones and progress via vendor dashboards.
• Ensure delivery of statistical outputs and datasets per Ipsen quality standards.
• Perform QC of analyses, SAS programming, and validation activities.
• Review CSRs and external communications related to study results.

Kenntnisse

Statistics leadership

SAS programming

R programming

Biostatistics

Stakeholder management

Cross-functional collaboration

Ausbildung

Master’s degree in Statistics

Master’s degree in Epidemiology

Tools

SAS

R

Jobbeschreibung

Excelya is seeking an experienced statistician to join a dedicated Statistics team overseeing Real-World Evidence and secondary use data studies. You will provide statistical leadership, review study protocols and SAPs, and supervise external providers to ensure timely, high-quality outputs that meet regulatory requirements.

The role involves collaboration with Biometry, Clinical Operations, Medical teams, and external partners, with a focus on data integrity and eTMF documentation.