Manager, Statistical Programming

ProClinical

Paris, France

1 day ago

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Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Expert

Working hours

Regular working hours

Job source

Clinical Data Repository SAS (Software) Xml Files Information Technology Data Management

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.

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).