R Developer - Clinical Data (100% remote)

Darize; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Darize is seeking an experienced R Developer for a global RBQM project. The role focuses on building and maintaining R-based analytical solutions, automating reporting, and supporting study configurations with CDISC standards.

You will work with clinical trial data, configure QTL logic, and collaborate across clinical operations, statistics, data management, quality and technology teams in a fully remote, international environment.

Qualifications

• Strong commercial experience in R development.
• Good knowledge of R and modular, reusable code for data analysis and reporting.
• Experience with clinical trial data in pharmaceutical, biotech or CRO environments.
• Knowledge of CDISC SDTM and clinical data structures.
• Experience with Quality Tolerance Limits (QTL) or statistical monitoring.
• Understanding of clinical trial quality and risk concepts (AEs, SAEs, protocol deviations).
• Data validation and quality control with attention to accuracy and reproducibility.
• Ability to work independently in a complex, international, cross-functional environment.
• Excellent English communication for collaboration and technical discussions.
• Knowledge of Git and automated testing or reproducible reporting tools is a plus.

Responsibilities

• Develop and maintain R-based analytical solutions supporting the RBQM ecosystem and statistical data monitoring.
• Create and enhance QTL reports, including QTL determination, target, SSLL and non-statistical reports.
• Configure study-specific QTL logic with thresholds, exposure periods, data paths and study-level adjustments.
• Work with clinical trial data and data structures based on CDISC SDTM.
• Automate data processing and reporting workflows for consistency and traceability.
• Perform quality checks and verification of calculations, parameters, dates and outputs.
• Collaborate with cross-functional stakeholders from clinical operations, statistics, data management, quality and technology.
• Document code and analytical logic for maintainable, auditable solutions.

Skills

R development

Statistical monitoring

QTL reporting

CDISC SDTM

Quality checks

Git

Automated testing

Tools

Git

Job description

We are looking for an experienced and independent R Developer to join a global pharmaceutical project focused on building a new unified ecosystem for Risk-Based Quality Management (RBQM). The solution is designed as a one-stop shop supporting study teams in identifying critical-to-quality factors, monitoring operational risks, harmonising issue management, and improving study and portfolio insights. The role combines R development, statistical data monitoring, QTL reporting and work with clinical trial data. The developer will build and enhance reliable analytical solutions, automate reporting processes, and support study-specific configurations and quality checks.

Work Mode: 100% remote

Job Responsibilities

• Develop and maintain R-based analytical solutions supporting the integrated RBQM ecosystem and statistical data monitoring.
• Create and enhance QTL reports, including QTL determination, target, SSLL and non-statistical reports.
• Configure study-specific QTL logic, including threshold limits, exposure periods, data paths and other study-level adjustments.
• Work with clinical trial data and support data structures based on CDISC standards, particularly SDTM.
• Automate data processing and reporting workflows to improve consistency, traceability and efficiency.
• Perform quality checks and report verification covering calculation logic, parameter names and units, exposure dates, study categories, threshold reference lines, plots and summary outputs.
• Collaborate with cross-functional stakeholders from clinical operations, statistics, data management, quality and technology teams.
• Document code and analytical logic and contribute to maintainable, reliable and audit-ready solutions.

Expectations

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

We Offer

• Dedicated Agent support - your go-to person for project continuity, client communication, day-to-day administration, and long-term professional development.
• Access to Darize Learning & Development - our internal development platform featuring webinars, industry reports and articles, access to learning platforms such as DataCamp and Coursera, and regular invitations to technical, business, and lifestyle events.
• Community and networking events - from Kick-Off trips, Christmas celebrations, and Summer Sport Games to family picnics and cultural events for you and your loved ones.
• Consultant Development Program - personalized professional development support based on current industry trends and market needs, delivered by experienced mentors and development advisors.
• Comprehensive benefits package - including private healthcare, life insurance, a sports card for you and your family members, as well as access to employee discounts in Poland and abroad.
• A community of experienced IT experts - exchange knowledge and collaborate with technology professionals who bring years of hands-on experience delivering complex technology projects (the average professional experience of our consultants in Poland exceeds 10 years).

About Darize

Some projects keep businesses running. Others help them evolve and grow. If you're more drawn to the latter, chances are we have a lot in common. At Darize, we work with organizations tackling complex technology challenges. In IT, one challenge is always around the corner: before one project ends, it’s already time to think about the next. Add uncertainty, rate negotiations, and administrative tasks, and it’s easy to lose focus on what matters most. That’s why we do more than connect experts with projects. We provide stability, access to ambitious technology initiatives, and a community of experienced professionals, so you can focus on what you do best. Darize brings together more than 2,500 consultants across 24 countries. In Poland, you may know us as 7N, the brand we built for over 20 years. We value expertise, long-term relationships, and a culture rooted in trust, quality, and Nordic values. We challenge the status quo and create an environment where people matter more than processes.