Key Responsibilities The job tasks listed below outline the scope of the position.
The application of these tasks may vary, based on current business needs.
Technical: - Perform consistency review of clinical trial documents including protocols, SAPs, CRFs, CSRs - Author and review simple and complex study TFL shells - Author and review simple and complex dataset standards - Perform data checks and data exploration (e.G. using frequencies, histograms) - Program and QC routine and ad hoc datasets and TFLs (in SAS) following specifications, applying good programming practice - Complete and review CDISC Validation tool reports - Ensure the appropriate standards are being applied and adhered to - Familiarisation with simple statistical techniques (e.G. t-test, ANOVA, regression, standard survival) - Review of project management related documents - Maintain study master file documents and any other documents that are required to be audit ready.
Required: Oncology experience.
R programming skills (Upskilling to Proficient) ADaM/TLF programming Preferred: R programming skills (Advanced to Expert) ISS/ISE/Submissions/RTQs. Familiarity with agile ways of working Prior experience with GSK tools