Clinical Data Programming & Analytics Manager

Daiichi Sankyo Co.; France; Hybride; EUR 90 000 - 150 000; Plein temps

Résumé du poste

Daiichi Sankyo is seeking a Manager, Data Programming, Analytics, and Reporting (m/f/d) to lead delivery of high-quality clinical data programming outputs across studies, including reports, listings, visualizations, and data validation deliverables.

You will act as a subject‑matter expert in programming, data listings, and data standards, partnering with study data managers and cross-functional teams to ensure timely, regulatory-ready analyses.

Qualifications

• Bachelor's degree or higher in life sciences or a related field.
• 5 to 8 years of global clinical trial experience in pharma, device, or CRO environments.
• Strong expertise in clinical programming methods, techniques, and data validation/reporting processes.
• Hands-on experience with SAS, Spotfire, Tableau, and JReview.

Responsabilités

• Lead delivery of high-quality, timely clinical data management programming outputs across assigned studies, including reports, listings, visualizations, and data validation deliverables.
• Serve as a subject matter expert in clinical programming, reporting, data listings, database extracts, and visualization tools.
• Develop, review, test, and maintain programming specifications, standard/custom programs, templates, and validation scripts in compliance with programming and regulatory standards.
• Partner with study data managers and cross-functional stakeholders to define requirements, confirm specifications, and support ad hoc reporting and external data needs.
• Oversee complex study deliverables such as edit checks, patient profiles, subject narratives, discrepancy reports, dose modification reports, and exception listings.
• Identify, manage, and resolve risks or issues affecting data quality, integrity, timelines, and regulatory submission readiness.
• Support critical study milestones, including interim analyses, database lock activities, medical coding support, and inspection/audit readiness.
• Mentor and train team members, provide technical guidance, and support use of data visualization tools.
• Drive continuous improvement by contributing to SOPs, policies, standards, reusability, process efficiency, and quality metrics.
• Promote collaboration, Daiichi Sankyo values, and strong working relationships with internal teams, external partners, and vendors.

Connaissances

Clinical programming

Data validation

Regulatory submission readiness

Project management

Quality assurance

Data visualization

Formation

Bachelor’s degree or higher in life sciences or related field

Outils

SAS

Spotfire

Tableau

JReview

CDISC SDTM/ADaM

EDC/CTMS/I RT/Veeva Vault/RAVE/InForm

Description du poste

Daiichi Sankyo is seeking a Manager, Data Programming, Analytics, and Reporting (m/f/d) to lead delivery of high-quality clinical data programming outputs across studies, including reports, listings, visualizations, and data validation deliverables.

You will act as a subject‑matter expert in programming, data listings, and data standards, partnering with study data managers and cross-functional teams to ensure timely, regulatory-ready analyses.