Tools & Standards Lead (Germany)

In this role, you own the strategy, governance, and evolution of the Statistical Computing Environment to enable efficient evidence generation, regulatory compliance, and modern analytics across clinical development. You collaborate with Biometrics, Data Science, IT, Quality, and external partners to ensure platform reliability and value. You drive adoption of modern technologies, set standards for reproducibility and auditability, and lead change management and training. This position offers the chance to shape a critical, validated computing platform in a global biopharma context and contribute to patient-focused outcomes.

• hybrid work model
• equal opportunity employer
• global exposure
• career growth opportunities
• collaborative culture
• focus on patient outcomes

• Own the vision, roadmap, and governance of the Statistical Computing Environment
• Act as the primary business owner for the platform
• Partner with Biometrics, Data Science, IT, Quality, and external vendors for reliability and value
• Ensure GxP compliance, validation, inspection readiness, and data integrity
• Translate clinical analytics needs into scalable platform capabilities for regulatory submissions
• Drive adoption of automation, AI, open-source tools, and DevOps practices
• Lead platform enhancements, change management, training, and user support
• Establish standards for reproducibility, traceability, auditability, and metadata-driven analytics
• Promote continuous improvement to increase efficiency, quality, and user experience
• Represent the organization in industry forums and contribute to best practices

• Deep understanding of the clinical development life cycle, statistical programming, and regulatory requirements
• Experience with validated computing environments, cloud platforms, software validation, and quality systems
• Strong leadership, stakeholder management, communication, and change management skills
• Ability to coordinate across stakeholder groups to achieve consensus and apply standards
• Ability to coordinate with management to align priorities and enable timely decisions
• Proven project management and strong organizational skills
• Knowledge of SAS, R, Python, Git, DevOps, AI-enabled workflows, and modern analytics platforms
• Knowledge of Domino Data Lab is preferred

• leadership
• stakeholder management
• communication
• SAS
• R
• Python