Minneapolis, Minnesota, United States
-Review and provide statistical support for development of protocols, responses to worldwide regulatory authorities. -Write and execute statistical analysis plans, design report templates, calculate sample sizes, create randomization schemes/schedules. -Analyze and report clinical trial data for multiple high-profile studies including a PMA submission and multiple international trials. -Provide tables, graphics, and statistical knowledge for scientific conference presentations and journal publications – including co-authorship in the New England Journal of Medicine. -Knowledgeable resource asked to participate in multiple department and cross-functional task forces to improve and enhance processes. -Actively participate in project timeline development and execution.
-Provided statistical support and analyzed data for multiple clinical trials. -Generated both internal and external reports summarizing statistical results. -Assisted with development and review of protocols and statistical analysis plans. -Assisted with design of Case Report Forms and creation of Oracle Clinical databases. -Produced Lead and validation programming and wrote generalized SAS macros for departmental use.
-Consulted with medical, marketing, and administrative investigators on analysis plans and results. -Ensured data reliability and analyzed data on multiple clinical trials. -Prepared statistical and graphical results, using SAS, for clinical trial presentations and publications. -Trained and mentored four new hires. -Phase I and Phase II clinical trial experience. -Established automated daily reports via an internal webpage and e-mail to create an infrastructure on a large colon cancer screening trial.