Senior Statistical Programming Lead - SDTM/ADaM Expert

Daiichi Sankyo Co.; France; Hybride; EUR 110 000 - 160 000; Plein temps

Résumé du poste

Daiichi Sankyo is seeking a Senior Manager, Statistical Programming to provide technical support to project teams and oversee outsourced programming activities. The role focuses on SDTM/ADaM datasets, TLFs, and regulatory submission readiness, with a drive to elevate efficiency and quality across the programming function.

Initial responsibilities include leading SDTM/ADaM reviews, developing standard templates and macros, and guiding internal programmers and vendors.

Qualifications

• 10+ years of experience in statistical programming supporting clinical trial analysis
• Experience with SAS macro and system utility development preferred
• Advanced SAS programming and CDISC SDTM/ADaM implementation in trials preferred
• Strong understanding of regulatory submission requirements and data standards

Responsabilités

• Provide statistical programming support to project teams and external vendors
• Review SDTM/ADaM datasets and TLFs for regulatory submissions
• Develop templates, macros and tools to improve efficiency and reproducibility
• Lead programming strategy for integrated efficacy and safety analyses
• Maintain SDTM/ADaM datasets and TLF standards in clinical trial data analysis

Connaissances

SAS macro development

CDISC SDTM/ADaM

Statistical programming

Regulatory submissions

Vendor management

Formation

Bachelor's degree in science/technical field

Master's degree preferred

Outils

SAS

Description du poste

Daiichi Sankyo is seeking a Senior Manager, Statistical Programming to provide technical support to project teams and oversee outsourced programming activities. The role focuses on SDTM/ADaM datasets, TLFs, and regulatory submission readiness, with a drive to elevate efficiency and quality across the programming function.

Initial responsibilities include leading SDTM/ADaM reviews, developing standard templates and macros, and guiding internal programmers and vendors.