Lead Biostatistical Programmer

Excelya; Boulogne-Billancourt; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading clinical research organization in Boulogne-Billancourt is seeking a statistical programming expert to lead clinical trial programming activities. This role involves creating CDISC-compliant datasets and mentoring team members. Candidates should possess a master's degree and strong proficiency in SAS. Join a dynamic team aiming to improve healthcare outcomes with innovative solutions.

Qualifications

• Advanced technical expertise in statistical programming with strong SAS skills.
• Proven experience with regulatory and submission guidelines.
• Excellent communication skills and fluency in professional English.

Responsabilités

• Lead statistical programming activities for clinical trials.
• Create and validate ADaM specifications and datasets.
• Develop CDISC-compliant datasets for regulatory submissions.
• Mentor and support statistical programmers within the project team.

Connaissances

SAS proficiency

Knowledge of CDISC standards

Leadership in programming activities

Formation

Master's degree in Pharma or Biostatistics

Description du poste

Overview

Hybrid Operations, Statistics & Programming — Full time

Boulogne-Billancourt, Île-de-France, France

Description

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Responsibilities

• Lead statistical programming activities for clinical trials within NITA and I-LCM projects.
• Create and validate ADaM specifications, ADaM datasets, and statistical outputs for CSR, iDMC, ad hoc analyses, and publications.
• Develop and validate CDISC-compliant datasets (ADaM, SDTM) to support regulatory submissions.
• Perform and oversee SAS programming, including development of macros and automated report generation.
• Validate and deliver define.xml, ADRG, and submission packages in accordance with regulatory requirements.
• Ensure compliance with international regulatory and data submission standards.
• Provide strategic oversight and guidance on programming processes and best practices.
• Act as a point of contact for cross-functional stakeholders, ensuring alignment between biostatistics, data management, and clinical teams.
• Mentor and support statistical programmers within the project team.

Qualifications

• Experience: Advanced technical expertise in statistical programming, with strong proficiency in SAS, proven experience with regulatory and submission guidelines.
• Skills: Solid knowledge of CDISC standards (ADaM, SDTM), strong understanding of the drug development lifecycle and functional interfaces, demonstrated ability to lead teams and manage programming activities in a complex, international environment.
• Education: Master\'s degree in a similar field (Pharma, biostatistics...)
• Languages: Excellent communication skills and fluency in professional English.

Benefits

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here\'s what makes us unique—

• We are a young, ambitious health company representing 900 Excelyates, driven to become Europe\'s leading mid-size CRO with the best employee experience.
• Our one-stop provider service model — offering full-service, functional service provider, and consulting — enables you to evolve through diverse projects.
• Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient\'s journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.