Overview
In this role as a Senior Statistical Programmer, you will leverage your advanced R programming skills to contribute to the analysis and reporting of unblinded clinical trial data for a global pharmaceutical company. Collaborating with cross-functional teams, you will ensure the accuracy and compliance of statistical outputs while playing a key role in regulatory submissions.
Responsibilities
- Support the analysis and reporting of clinical trial data using R programming.
- Produce safety and efficacy tables, listings, and graphs.
- Monitor data, ensuring safety and adverse-event reporting.
- Respond to regulatory agency queries and submissions.
- Work with unblinded data while implementing appropriate access controls.
- Collaborate with other research and analysis teams to ensure data quality.
Requirements
- Proven experience in R programming, with a focus on creating complex graphical outputs.
- Strong foundational knowledge in statistics and data analysis.
- Experience in producing clinical trial reports, including safety and efficacy documentation.
- Familiarity with data monitoring and adverse-event reporting processes.
- Previous involvement with regulatory submissions and addressing agency inquiries is essential.
- Experience handling unblinded data is preferred.