Karen Copeland, Ph.D., has more than 25 years of experience as a statistical consultant with a focus on general/graphical data analysis, design of experiments, sample size determination, and FDA documentation. Dr. Copeland is the principal of Boulder Statistics, a consultancy firm specializing in BioStats for medical device and diagnostic companies. Dr. Copeland has worked with over a dozen medical device companies at all stages of product development, from basic R&D through FDA filings. Dr. Copeland has assisted in obtaining FDA clearance for several products, including the Tivic Health ClearUP device.
In addition to her medical device experience, Dr. Copeland has worked with clients in pre-clinical pharmaceutical production, veterinary science, marketing, product usability, food production, and engineering industries. She has authored two books and a dozen peer-reviewed journal articles.
Dr. Copeland received a BA from St. Olaf College, and a MS and Ph.D. in Mathematical Sciences from Clemson University.