Lead Biostatistical Programmer

About the Job 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 innovatio and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth. Activities Lead statistical programming activities for clinical trials within NITA and I-LCM projects. Create and validate ADaM specifications, ADaM datasets, and statistical outputs for Clinical Study Reports (CSR), iDMC reviews, ad hoc analyses, and scientific 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 tools. Validate and deliver define.xml, Analysis Data Reviewer’s Guide (ADRG), and full submission packages in accordance with current regulatory guidelines. Ensure compliance with international regulatory and data submission standards (e.g., FDA, EMA). Provide strategic oversight and guidance on statistical programming processes and industry best practices. Maintain a strong understanding of drug development processes and functional interdependencies (e.g., data management, clinical operations). Act as a key point of contact for cross-functional stakeholders, ensuring effective communication and alignment between biostatistics, clinical, and data teams. Mentor and support junior statistical programmers within the project team.

Requirements: About You At Excelya, taking audacious steps is encouraged, so we're looking for individuals who are ready to grow with us and share our values. Experience : Proven experience in statistical programming for clinical trials, including advanced proficiency in SAS. Hands-on experience with creation and validation of ADaM and SDTM datasets, statistical outputs, and submission deliverables. Prior experience with regulatory submission requirements and documentation (e.g., define.xml, ADRG, eCTD packages). Skills : Solid knowledge of CDISC standards (ADaM, SDTM), advanced SAS programming (macros, automation), strong understanding of the drug development lifecycle and cross-functional collaboration, strategic thinking, ability to work autonomously in an international environment. Education : Master's degree in Biostatistics, Mathematics, Computer Science, Life Sciences, or a related field. Languages : Professional fluency in English (written and spoken). Comfortable working in an international and multicultural setting.

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.