Project Programming Lead

Main Responsibilities

• Lead scientific programming deliverables: provide leadership, guidance, and hands-on support for high-quality, timely programming outputs in compliance with internal standards, SOPs, and regulatory requirements.
• Manage project planning & resources: plan and track programming activities, timelines, and resource utilization in a global setting.
• Ensure standardization & consistency: maintain consistency in specifications and programming deliverables across individual studies and integrated analyses.
• Drive regulatory submissions: lead regulatory submission activities, including electronic submission packages, ensuring CDISC (SDTM/ADaM) data packages comply with Health Authority expectations.
• Oversee outsourcing engagements: manage interactions with external resources.
• Collaborate cross-functionally: partner with project statistician(s) and contribute inputs in clinical project meetings.
• Transversal responsibility/process improvement: contribute to process improvement and outsourcing operation management (CRO partnership oversight, KPI follow-up, lessons learned meetings, partnership governance/process documentation, and shared IT environments such as Teams/SharePoint).
• Mentor junior staff on programming techniques and standards implementation.

• Bachelor’s degree in Statistics, Mathematics, Computer Science or related health sciences.
• 7+ years hands-on SAS or R programming experience; proficiency in CDISC standards (SDTM/ADaM) and regulatory submission requirements.

• Experience coordinating global end-to-end study/project-level programming deliverables; experience with third-party vendors.
• Leadership and intercultural teamwork skills; ability to lead change and drive innovation/improvement.
• Experience implementing automation and digital transformation initiatives.
• Fluent in English; additional languages a plus.

• Health and wellbeing benefits, including at least 14 weeks’ gender-neutral parental leave.