Karen Kesler, Ph.D.

Assistant Vice President, Operations

Karen Kesler

Karen Kesler, Ph.D.

Assistant Vice President, Operations

Dr. Karen Kesler is a gifted statistician, adaptive design expert, and respected leader at Rho and in the clinical research industry. As the Primary Investigator of a large coordinating center funded by the National Institute of Allergy and Infectious Diseases, she leads a multi-disciplinary team of over 100 people that provides clinical research operations and management support to a portfolio of 79 NIH-sponsored clinical trials and observational studies. This coordinating center supports six clinical research networks in such diverse therapeutic areas as allergy, asthma, immune tolerance, atopic dermatitis, autoimmune disease and organ transplantation. Prior to this center, she has worked as a PI and Co-PI in organ transplant, atopic dermatitis, and sickle cell disease.  In addition to supporting federally funded studies, Dr. Kesler has a long history of supporting studies in the commercial pharmaceutical arena.

Whether she’s developing novel adaptive study designs, helping sponsors meet their specific research goals, or improving existing tools and developing new ones to facilitate project implementation, Dr. Kesler is always finding ways to enhance clinical research. Her expertise in study design informs an advanced insight that allows her to provide expert guidance to stakeholders. If a concept is limiting, she has an ability not only to identify it but also to help all stakeholders understand the inherent possibilities of another concept. Dr. Kesler has written protocols, statistical analysis plans, and performed the analyses for many adaptive studies, including sample size recalculations, pruning designs, Bayesian dose escalation studies, and adaptive randomizations.