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 Advancing Clinical Therapeutics Globally (ACTG) network, where she works with cross-functional teams to develop clinical trial protocols (e.g., strategy, sample size, estimands, eCRFs) and statistical analysis plans (SAPs), oversees the implementation and monitoring of studies, leads primary and secondary analyses (read outs), and authors statistical analysis reports, as well as manuscripts and abstracts for public dissemination. With her work with the ACTG she has served in a leadership role as the statistical representative on the Comorbidities Translation Science Group (CTSG) where she provides statistical oversight of all CTSG-related projects across numerous therapeutic areas (e.g., MASLD, CVD, obesity, oncology, inflammation and immunology).

Recently, she took on the role of lead statistician on ACTIV-2, a fast-moving, large-scale adaptive platform trial, that considered ten novel investigational agents for treatment of outpatients with COVID-19. In this role, she regularly interacted with leadership from the Division of AIDS at the NIH regarding the study design, progress, and implementations issues, liaised with the study’s pharmaceutical partners to provide review/scientific oversight of all analyses/statistical issues across the platform, provided statistical oversight of CRO partners, and mentorship to the large CBAR biometrics team.

Her primary research interest are varied and include understanding mechanisms of sustained systemic inflammation and immune activation in PWH and metabolic complications of HIV, and statistical issues related to analyzing laboratory-based biomarker data.

Education and Training

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

Publications

• Implementation of a seamless phase 2/3 study design in the setting of an emergent infectious disease pandemic: Lessons learned from the ACTIV-2 platform COVID-19 treatment trial.

  Giganti MJ, Chew KW, Moser C, Eron JJ, Pinilla M, Li JZ, Ritz J, Javan AC, Wohl DA, Daar ES, Currier JS, Smith DM, Hughes MD. Contemp Clin Trials 2025

  PMID: 40147543

• Effects of Semaglutide on Muscle Structure and Function in the SLIM LIVER Study.

  Ditzenberger GL, Lake JE, Kitch DW, Kantor A, Muthupillai R, Moser C, Belaunzaran-Zamudio PF, Brown TT, Corey K, Landay AL, Avihingsanon A, Sattler FR, Erlandson KM. Clin Infect Dis 2025 02 24

  PMID: 39046173

• Viral and Symptom Rebound Following Anti-Severe Acute Respiratory Syndrome Coronavirus 2 Monoclonal Antibody Therapy in a Randomized Placebo-Controlled Trial.

  Chew KW, McGinley B, Moser C, Li JZ, Evering TH, Ritz J, Javan AC, Margolis D, Wohl DA, Hughes MD, Daar ES, Currier JS, Eron JJ, Smith DM. J Infect Dis 2025 Feb 04

  PMID: 39400063

• Tixagevimab/cilgavimab or placebo for COVID-19 in ACTIV-2: Safety, pharmacokinetics and neutralizing and anti-drug antibodies.

  Bender Ignacio RA, Chew KW, Moser C, Currier JS, Eron JJ, Javan AC, Giganti MJ, Ritz J, Gibbs M, Kouekam HT, Esser MT, Daar ES, Choudhary M, Deo R, Fletcher CV, Li JZ, Hughes MD, Smith D, Wohl DA. iScience 2025 Mar 21

  PMID: 40124489

• Early antiviral CD4+ and CD8+ T cells are associated with upper airway clearance of SARS-CoV-2.

  Ramirez SI, Lopez PG, Faraji F, Parikh UM, Heaps A, Ritz J, Moser C, Eron JJ, Wohl D, Currier J, Daar ES, Greninger A, Klekotka P, Grifoni A, Weiskopf D, Sette A, Peters B, Hughes MD, Chew KW, Smith DM, Crotty S. JCI Insight 2024 Dec 20

  PMID: 39704169