Carlee B Moser

Carlee Moser is a Senior Research Scientist at the Center for Biostatistics in AIDS Research within the Department of Biostatistics at the Harvard T. H. Chan School of Public Health. She has extensive experience in statistical methods in epidemiology, observational studies, and clinical trials. She has worked with investigators at the Framingham Heart Study on multiple projects to understand cardiovascular risk factors and biomarkers, and their relationship to health outcomes such as atrial fibrillation, stroke, and cardiovascular disease. Her primary role with in CBAR is as a senior statistician with the AIDS Clinical Trials Group (ACTG) where she has collaborated with clinical investigators on the development of clinical trial protocols, and has overseen the monitoring and analyses of studies. With her work with the ACTG she has served in a leadership role as the statistical representative on the End-Organ Disease and Inflammation Translation Science Group (EOD/iTSG) where she provides statistical review and support for the development of new proposals, as well as management of statistical resources. Her primary research interest are varied and include understanding mechanisms of sustained systemic inflammation and immune activation in HIV+ populations and metabolic complications of HIV, and statistical issues related to analyzing laboratory-based biomarker data.

Recently, she took on the role of lead statistician working on the Operation Warp Speed platform trial of potential outpatient treatments for COVID-19. This trial is a major initiative of a collaboration between NIH, FDA and pharmaceutical companies known as ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines). The aim is to evaluate candidate monoclonal antibodies, and other immunological and antiviral agents using a standardized protocol with an adaptive design, including a possibly seamless phase 2 to phase 3 trial component.