Senior Statisticien RWE

Excelya; Boulogne-Billancourt; On-site; EUR 90,000 - 120,000; Full time

Job summary

Excelya is seeking a Senior Statistics professional to join the Statistics team overseeing Real-World Evidence, non-interventional, and Secondary Use of Data projects. You will provide statistical leadership, review protocols and SAPs, supervise external vendors, ensure quality and timely outputs, and collaborate across Biometry, Clinical Operations, and Medical teams.

The role requires a Master’s degree in Statistics or related field and extensive experience in pharmaceutical analytics, with

Qualifications

• Master's degree in Statistics, Biostatistics, Epidemiology, or related field.
• Very strong experience in statistics and statistical programming within pharmaceutical/biotech/healthcare industries, including RWE, non-interventional, and SUD projects.
• Hands-on SAS programming and statistical validation experience.

Responsibilities

• Review study synopses, protocols, sample size calculations, design, endpoints, and statistics.
• Oversee SAPs, TFLs, and interim analyses from external vendors.
• Monitor study milestones and vendor dashboards to track progress.
• Ensure timely, high-quality statistical outputs and datasets per Ipsen quality standards.
• Perform QC of analyses and CSR reviews; manage external communications.
• Collaborate with Biometry, Clinical Operations, Medical teams and partners.
• Maintain complete study documentation with eTMF compliance.

Skills

SAS programming

R programming

Healthcare data

Stakeholder management

Education

Master's degree in Statistics

Job description

Join Excelya , where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role offers an exciting opportunity to join a Statistics team overseeing Real-World Evidence (RWE), non-interventional, and Secondary Use of Data (SUD) studies. You will provide statistical leadership, review study protocols and analysis plans, supervise external service providers, ensure the quality and timely delivery of statistical outputs, and work closely with cross-functional teams to support evidence generation and regulatory reporting

Key Responsibilities :

• Review study synopses and protocols, including sample size calculations, study design, endpoints, and statistical methodologies.
• Oversee statistical deliverables from external service providers, including Statistical Analysis Plans (SAPs), TFLs, and interim analyses.
• Monitor study statistical milestones and track operational progress through vendor dashboards.
• Ensure the timely delivery of statistical outputs and analysis datasets in compliance with Ipsen quality standards.
• Perform quality control of statistical analyses, including SAS programming and programming validation activities.
• Review clinical study reports (CSRs) and all external communications related to study results and analyses.
• Collaborate closely with cross-functional stakeholders, including Biometry, Clinical Operations, Medical teams, and external partners.
• Ensure complete and accurate maintenance of study documentation, including accountability for eTMF completion.

At Excelya, we encourage everyone to be bold, challenge themselves, and unlock their full potential. We are looking for professionals who share our values and are eager to grow in a dynamic and stimulating environment.

Education :

Master's degree in Statistics, Biostatistics, Epidemiology, or a related scientific discipline.

Experience :

Very strong experience in statistics and statistical programming within the pharmaceutical, biotech, or healthcare industry, including significant exposure to Real-World Evidence (RWE), non-interventional studies, and Secondary Use of Data (SUD) projects

Skills :

Hands-on experience with SAS programming and statistical validation.

Experience with R and/or large healthcare databases (claims databases, EHR/EMR, registries) is considered a strong asset.

Excellent communication and stakeholder management skills, with the ability to collaborate effectively in a cross-functional and international environment.

Languages :

Fluent English, both written and spoken.

Why join us?

At Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare. Here's what makes us unique: We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience. Our "one-stop provider" service model-combining full-service, functional service provider, and consulting-allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey. Excelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.