Senior ADS Programmer(m/w/x)

Anforderungen

• Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field
• Minimum 5 years statistical programming experience in clinical development, or advanced degree with 3 years equivalent experience
• Proficiency/working knowledge of modern programming language (SAS or R) and visualization/review tools
• Deep understanding of statistical quality, endpoints, QC processes
• Experience with CDISC standards (SDTM and ADaM)
• Expertise in handling/analyzing multi-modal data
• Ability to deliver programming outputs independently
• Respect for cultural differences in global workplace
• Fluency in English
• Attention to detail for regulatory submission processes/documentation
• Critical thinking, strong organizational/problem-solving skills
• Experience in cross-functional global study teams
• Effective communication skills, translating complex statistical concepts
• Experience with multiple phases of drug development
• Excellent communication skills, influencing/translating complex data
• Willingness to adapt, grow, and evolve

Aufgaben

• Transform statistical analysis plans into programming deliverables.
• Facilitate robust, timely, and decision-enabling analytics.
• Develop, validate, and maintain SDTM and ADaM datasets.
• Develop, validate, and maintain statistical outputs (TLFs).
• Ensure programming accuracy, traceability, and compliance.
• Develop and support programming outputs for biomarker data.
• Develop and support programming outputs for real-world data.
• Collaborate on exploratory analyses for drug development.
• Support creation and refinement of interactive analytical tools.
• Enable dynamic exploration of integrated datasets.
• Provide programming leadership for assigned studies.
• Coordinate programming deliverables with partners.
• Interpret statistical analysis plans.
• Translate plans into programming specifications.
• Ensure scientific rigor in programming outputs.
• Troubleshoot and resolve technical programming challenges.
• Proactively identify programming risks.
• Implement effective programming solutions.
• Contribute to design and maintenance of standard macros.
• Contribute to design and maintenance of reusable components.
• Document programming workflows.
• Maintain programming audit trails.
• Ensure study files are complete and traceable.
• Ensure study files are inspection-ready.
• Collaborate with stakeholders to define timelines.
• Collaborate with stakeholders to define deliverables.
• Engage in process improvement activities.
• Engage in innovation activities.
• Participate in learning activities.
• Grow knowledge of clinical research.
• Grow knowledge of programming standards.

Berufserfahrung

Ausbildung

Sprachen

Tools & Technologien