Overview
The Senior Statistical Programmer will collaborate with a global pharmaceutical team to analyze and report on unblinded clinical trial data, utilizing advanced R programming skills. This fully remote role offers the opportunity to work with complex datasets, producing essential safety and efficacy reports while adhering to regulatory standards.
Responsibilities
- Support the analysis and reporting of clinical trial data using advanced R programming.
- Create complex graphical outputs and produce safety and efficacy tables, listings, and graphs.
- Monitor data and report on safety and adverse events.
- Collaborate on regulatory submissions and address authority queries.
- Ensure compliance with access controls, particularly when working with unblinded data.
- Deliver high-quality statistical programming outputs within project timelines.
Requirements
- Proven experience in R programming with a focus on statistical analysis.
- Strong statistical knowledge and experience in clinical trial reporting.
- Demonstrated ability to produce safety and efficacy tables, listings, and graphs.
- Experience in data monitoring and reporting of safety and adverse events.
- Familiarity with regulatory submission processes and responding to authority queries.
- Experience working with unblinded data is preferred.