Location:

Primany location: France

Second location: Germany

Roles and Responsibilities

• 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.

Education & Experience

• Bachelor’s degree or higher in life sciences or a related field.
• 5 to 8 years of global clinical trial experience in pharmaceutical, device, or CRO environments.
• Strong expertise in clinical programming methods, techniques, and data validation/reporting processes.
• Hands-on experience with reporting and visualization tools such as SAS, Spotfire, Tableau, and JReview.
• Knowledge of clinical data standards, including CDISC, CDASH, and SDTM/ADaM.
• Familiarity with clinical systems and technologies such as EDC, CTMS, IRT, Veeva Vault, RAVE, and InForm.
• Strong skills in project management, validation, QC/testing, documentation, and archival of clinical data programming deliverables.
• Demonstrated ability to work independently, manage multiple priorities, solve complex problems, and collaborate across functions, cultures, and experience levels.