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# Manager, Statistical Programming

- **Company:** ProClinical
- **Location:** Paris, France (Remote available)
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Clinical Data Repository, SAS (Software), Xml Files, Information Technology, Data Management
- **Published:** September 4, 2026
- **Apply:** https://www.proclinical.com/Apply?jid=24166

## About the Role

* Advanced proficiency in SAS programming within a clinical research environment.
 * Strong knowledge of CDISC standards, including SDTM and ADaM.
 * Proven experience in developing and programming SDTM and ADaM datasets.
 * Expertise in generating reports, TLFs, and other statistical outputs.
 * Experience supporting clinical development programs and trials.
 * Familiarity with regulatory submission processes (e.g., NDA, sNDA, or equivalent).
 * Strong collaboration and communication skills, with the ability to work effectively in multidisciplinary and international teams.
 * Proactive stakeholder management and decision-making abilities.
 * Excellent planning, organizational, and prioritization skills.
 * Ability to mentor, train, and influence team members and project teams.
 * Knowledge of R or other statistical programming tools is a plus.
 * Solid understanding of the clinical data lifecycle and data management processes.
 * Educational background in Statistics, Mathematics, Computer Science, Life Sciences, or a related field (Master's degree preferred; Bachelor's degree considered with relevant experience).

## Description

* Lead statistical programming activities for multiple clinical studies and development programs.
 * Ensure timely delivery of high-quality programming deliverables, whether produced internally or by external vendors.
 * Maintain consistency in processes, standards, and execution of programming activities across assigned studies.
 * Support and oversee programming activities related to global regulatory submissions and responses to health authorities.
 * Manage outsourced programming activities, ensuring adherence to quality, budget, and timelines.
 * Review and supervise the production of programming deliverables, including:
 * Tables, Listings, and Figures (TLFs)
 * SDTM and ADaM datasets
 * xml files and associated documentation
 * Contribute to the development, implementation, and continuous improvement of programming standards, SOPs, validation processes, and best practices.
 * Maintain study documentation in compliance with regulatory requirements, ensuring audit and inspection readiness.
 * Identify opportunities to optimize workflows, promote innovative approaches, and address programming needs for increasingly complex study protocols and methodologies.


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