Carlee B Moser

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Biography

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.

Education and Training

• B.S., Statistics
  University of New Hampshire
• M.A., Biostatistics
  Boston University
• PhD, Biostatistics
  Boston University

Publications

• Safety and Efficacy of SAB-185 for Nonhospitalized Adults With COVID-19: A Randomized Clinical Trial.

  Chew KW, Taiwo BO, Moser C, Daar ES, Wohl DA, Ritz J, Javan AC, Li JZ, Fischer W, Greninger AL, Bausch C, Luke T, Call R, Neytman G, Giganti MJ, Fletcher CV, Hughes MD, Eron JJ, Currier JS, Smith DM. J Infect Dis 2024 Nov 15

• SARS-CoV-2 Monoclonal Antibody Treatment Followed by Vaccination Shifts Human Memory B-Cell Epitope Recognition, Suggesting Antibody Feedback.

  Bloom N, Ramirez SI, Cohn H, Parikh UM, Heaps A, Sieg SF, Greninger A, Ritz J, Moser C, Eron JJ, Bajic G, Currier JS, Klekotka P, Wohl DA, Daar ES, Li J, Hughes MD, Chew KW, Smith DM, Crotty S, Coelho CH. J Infect Dis 2024 Nov 15

• Mortality and Associated Risk Factors Among People Living With HIV With Kaposi Sarcoma: A5263/AMC066 and A5264/AMC067.

  Chagomerana MB, Moser CB, Kang M, Umbleja T, Hughes MD, Campbell TB, Krown SE, Borok MZ, Samaneka W, Ngongondo M, Nyirenda M, Langat DC, Hoagland B, Burger H, Busakhala N, Njiru E, Mwelase N, Mngqibisa R, Hosseinipour MC. J Acquir Immune Defic Syndr 2024 Nov 01

• The statistical design and analysis of pandemic platform trials: Implications for the future.

  Lindsell CJ, Shotwell M, Anstrom KJ, Berry S, Brittain E, Harrell FE, Geller N, Grund B, Hughes MD, Jagannathan P, Leifer E, Moser CB, Price KL, Proschan M, Stewart T, Thomas S, Touloumi G, LaVange L. J Clin Transl Sci 2024

• SARS-CoV-2 Plasma Antibody and Nucleocapsid Antigen Status Predict Outcomes in Outpatients With COVID-19.

  Jilg N, Giganti MJ, Chew KW, Shaw-Saliba K, Ritz J, Moser C, Evering TH, Daar ES, Eron JJ, Currier JS, Hughes MD, Lane HC, Dewar R, Smith DM, Li JZ. Clin Infect Dis 2024 Oct 15