Contribute to efficient study design, preparing statistical consideration sections and providing input into other protocol sections. Perform simulations for ED statistical innovative designs. Prepare statistical analysis plans including table shells. Analyze clinical trial data; work with programmers to provide tables, listings and graphs, including ad hoc validation. Maintain / upgrade home-grown ED Stats software with ED Bayesian Methods. Review, synthesize, interpret and report analysis results. Provide ad hoc data driven analyses. Provide statistical input for the preparation of final study reports and other required documents. Escalates issues to functional management as necessary. Makes recommendations or resolves technical, quality, and timeline issues. Skills/Knowledge Required • MS or Ph.D in Statistics. • At least 2 years clinical drug development experience with a Master's degree; or no additional experience with a Ph.D. as a study statistician. • 1 plus years statistical computing experience (e.g. SAS, R, or other statistical computing software) • Knowledge of MS Office products (Word, Excel, PowerPoint) • Demonstrated skill in statistical methodologies and data analysis, especially in Bayesian methods. • Knowledge of clinical trial design concepts. Also knowledge of Bayesian innovative designs in ED • Demonstrated ability to learn statistical regulatory requirements. • Good interpersonal, communication, writing and organizational skills. • Ability to work in a team environment with medical personnel, clinical monitors, data managers, programmers and medical writers.
Source: Job Diva – Job Listing