Senior Statistical Programming Lead – Clinical Trials

R&D Partners; Paris; Sur place; EUR 85 000 - 90 000; Plein temps

Résumé du poste

R&D Partners in Paris is seeking a Statistical Programming Lead to oversee statistical programming for clinical studies, ensuring high-quality deliverables and regulatory readiness.

You will lead programming tasks across multiple studies, coordinate with external teams, review datasets, TLFs, and documentation, and support NDA/sNDA submissions. A degree in Statistics, Mathematics, Computer Science, or a related field is required, with expertise in SAS and CDISC standards.

Qualifications

• Proficient in SAS within clinical trials or related field.
• Familiar with CDISC SDTM and ADaM standards.
• Experience creating TLFs for clinical studies.
• Knowledge of regulatory submission processes and audit-ready documentation.
• Strong clinical data management understanding and ability to manage multiple projects.

Responsabilités

• Manage and lead programming tasks across multiple clinical studies.
• Ensure timely and high-quality delivery of programming outputs.
• Oversee and coordinate work with external programming teams and vendors.
• Support global regulatory submissions and address questions from health authorities.
• Review and ensure the quality of datasets, tables, listings, figures, and related documentation.
• Promote consistency in programming processes, standards, and documentation.
• Identify opportunities for process improvements and implement innovative solutions.

Connaissances

SAS programming

CDISC SDTM/ADaM

TLFs

Regulatory submissions

Clinical data management

R programming

NDA submissions

Formation

Statistics/Mathematics/CS degree

Outils

R programming

SAS

Description du poste

R&D Partners in Paris is seeking a Statistical Programming Lead to oversee statistical programming for clinical studies, ensuring high-quality deliverables and regulatory readiness.

You will lead programming tasks across multiple studies, coordinate with external teams, review datasets, TLFs, and documentation, and support NDA/sNDA submissions. A degree in Statistics, Mathematics, Computer Science, or a related field is required, with expertise in SAS and CDISC standards.