at Incyte Corporation in Wilmington, Delaware, United States
Work as a clinical trial level statistician supporting oncology clinical trials under supervision. Provide statistical review of analysis datasets specifications and outputs, and guide programmers on programming work. Review and validate analysis outputs and responsible for output deliverable during dry-run, interim analysis, and final analysis. Author statistical analysis plan and output shells. Attend clinical study team meetings and provide support when there are statistical related questions from study team, health authorities, or ethnic committees. Review study protocol, case report form (CRF), CRF completion guideline, and other study related documents including but not limited to data management plan, edit checks, Data Monitoring Committee Charter, imaging charter, protocol deviation list, etc. Author statistics section of study protocol including sample size estimation, analysis population, and endpoints. Assist in writing relevant sections of clinical study report. Support investigational compound annual safety and investigator brochure update.