Ed Volpe

Background

About Ed Volpe

Pharmaceutical research and development professional with over 14 years of experience performing roles in areas of statistics, programming, data management and medical writing. Extensive experience managing 3rd party vendors including bid negotiation, establishing timelines, providing technical guidance, reviewing and tracking deliverables, forecasting resources, transitioning projects between vendors, collecting and reporting metric data, and remediating performance issues. Led internal and 3rd party statistical, programming, data management and medical writing activities for clinical trials including statistical input into protocols, statistical analysis plans (SAP), database design activities (CRF design, UAT), programming plans and integrated programming plans for submissions (list of tables, mock table shells, analysis specifications, CDISC dataset specifications and QC plans), tables, listings and figures (TLFs), data set release, top line results and authoring clinical study reports (CSRs). Detail-oriented focus with leadership in developing and implementing high quality processes and procedures consistent with GCPs. Experience in women’s health, urology, coagulation, endocrinology, analgesia, cardiovascular and inflammation therapeutic areas as well as medical devices. Bachelor of Science degree in Mathematics from Drexel University and a Master of Science degree in Statistics from Virginia Tech University.