Principal ADS Programmer(m/w/x)

Anforderungen

• Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field
• Minimum 8 years statistical programming experience in clinical development, or advanced degree with 6 years equivalent experience
• Proven ability to lead programming efforts
• Expertise in modern programming languages (R, Python) and review/visualization tools (SAS)
• Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements
• Expertise in handling/analyzing multi-modal data
• Deep expertise in statistical quality, endpoints, QC processes
• Respect for cultural differences in global workplace
• Fluent English and excellent communication skills
• Experience preparing eCTD submissions and working with regulatory authorities
• Involvement in automation or advanced analytics projects (AI/ML)
• Ability to coach and mentor colleagues
• Strong systems thinking and awareness of enterprise data/technology landscape
• Experience in cross-functional global study teams
• Experience with multiple phases of drug development
• Excellent communication, influence, and data translation skills

Aufgaben

• Lead statistical programming for studies and submissions.
• Lead programming for research efforts.
• Deliver validated SDTM and ADaM datasets.
• Deliver validated tables, listings, and figures.
• Integrate and analyze diverse data types.
• Enable deeper scientific insights.
• Collaborate on exploratory analyses.
• Generate hypotheses from data.
• Support data-driven decision-making.
• Lead development of data insights engines.
• Lead development of analytical applications.
• Visualize complex datasets.
• Enable dynamic data exploration.
• Develop innovative programming solutions.
• Implement automation and scalable approaches.
• Improve programming efficiency and reliability.
• Translate statistical analysis plans.
• Develop executable programming strategies.
• Ensure accurate analytical intent in outputs.
• Apply problem-solving and technical rigor.
• Drive standardization and reuse of code.
• Develop programming libraries and frameworks.
• Ensure inspection readiness and documentation.
• Maintain traceable workflows and audit trails.
• Adhere to internal and regulatory standards.
• Contribute to functional improvement initiatives.
• Enhance tools, templates, and best practices.
• Elevate quality and operational excellence.
• Ensure execution quality and timely delivery.
• Adhere to programming standards and strategy.
• Mentor less experienced colleagues.
• Promote software development best practices.
• Promote analytics tooling best practices.
• Foster scientific collaboration.

Berufserfahrung

Ausbildung

Sprachen

Tools & Technologien