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