Senior Statistical Programming Lead – Regulatory Submissions

Ipsen; Paris; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Ipsen is seeking a Senior Manager and lead programmer to drive multiple studies within the Statistical Programming function, ensuring quality and on-time delivery, either in-house or via CROs.

The role requires hands-on and managerial expertise, with strong SAS skills, CDISC knowledge, and experience in SDTM/ADaM programming for regulatory submissions. English proficiency is essential; French preferred. Based in Paris, France.

Qualifications

• Proficiency in SAS programming for global studies.
• Familiar with CDISC standards (SDTM/ADaM).
• Experience in SDTM and ADaM specification and programming.
• Experience in reporting and TFL programming.
• 8+ years’ programming experience in pharma/biotech/CRO environment.

Responsabilités

• Lead programmer on multiple studies to ensure quality and timely delivery, in house or via CROs.
• Oversee programming preparation for global regulatory submissions and respond to health authority questions.
• Oversee outsourced programming to maintain quality, budget, and timelines.
• Contribute to development and implementation of SAS standards, SOPs and documentation.
• Ensure study-related documentation is audit-ready and compliant.

Connaissances

SAS

CDISC

SDTM

ADaM

Reporting

TFL

Audit readiness

English

French

Formation

Bachelor or MSc in Statistics/Mathematics/Scientific Discipline

Description du poste

Ipsen is seeking a Senior Manager and lead programmer to drive multiple studies within the Statistical Programming function, ensuring quality and on-time delivery, either in-house or via CROs.

The role requires hands-on and managerial expertise, with strong SAS skills, CDISC knowledge, and experience in SDTM/ADaM programming for regulatory submissions. English proficiency is essential; French preferred. Based in Paris, France.