R Developer - Clinical Data

Darize brings together more than 2,500 consultants across 24 countries. In Poland, the company is known as 7N, a brand established for over 20 years. Darize collaborates with organizations facing complex technology challenges and provides stability, access to technology initiatives, and a community of experienced professionals.

• Strong commercial experience in R development with ability to deliver solutions independently.
• Very good knowledge of R including writing clean, modular, and reusable code for data analysis and reporting.
• Experience working with clinical trial data in pharmaceutical, biotechnology, or CRO environments.
• Knowledge of CDISC SDTM standards and understanding of clinical data structures.
• Experience with Quality Tolerance Limits (QTL) or statistical monitoring in RBQM.
• Understanding of clinical trial quality and risk concepts including adverse events and protocol deviations.
• Experience in data validation and quality control with attention to accuracy and reproducibility.
• Ability to work independently in complex, international, and cross-functional environment.
• Good command of English for effective collaboration and technical communication.
• Knowledge of Git, automated testing, or reproducible reporting tools is an advantage.

• Develop and maintain R-based analytical solutions supporting the RBQM ecosystem and statistical data monitoring.
• Create and enhance Quality Tolerance Limits (QTL) reports including determination, target, SSLL, and non-statistical reports.
• Configure study-specific QTL logic such as threshold limits, exposure periods, and data paths.
• Work with clinical trial data structured according to CDISC standards, particularly SDTM.
• Automate data processing and reporting workflows to improve consistency and efficiency.
• Perform quality checks and verify report accuracy covering calculation logic, parameter names, units, exposure dates, and plots.
• Collaborate with clinical operations, statistics, data management, quality, and technology teams.
• Document code and analytical logic for maintainable and audit-ready solutions.