Lead Biostatistical Programmer H/F - 95

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.AbouttheJob

JoinExcelya,whereAudacity,Care,andEnergydefinewhoweareandhowwework.Webelieveincreatingboldsolutionsandfosteringaninclusiveenvironmentwherecollaborationandindividualgrowthgohandinhand.

Thisroleisanexcitingopportunitytocontributetoadynamic,ambitiousteam.Youwillplayacriticalpartindrivinginnovatio andmakinganimpactintheclinicalresearchspace,whileenjoyingastimulatingprofessionalenvironmentthatencouragespersonalandintellectualgrowth.

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.