Welcome to Katherine Kacena Consulting



Biostatistical Consulting in Drug and Device Development

Katherine Kacena is a Statistical Consultant with 25 years of research experience, across industry, academia, and in collaborations with non-governmental and governmental institutions. Katherine received her PhD at the Johns Hopkins School of Hygiene and Public Health, now the Bloomberg School of Public Health, in the Department of International Health, in the challenging Disease Control track, which was equally weighted in the studies of biostatistics, epidemiology, and molecular biology with applications to international health. In addition, she has completed a two-year Visiting Fellowship in the Statistics Department, Harvard University (Cambridge, MA) studying causal inference and multiple imputation.

Therapeutic or Functional Area of Expertise

Oncology, Cardiovascular Diseases, Autoimmune Diseases, Medical Devices, Infectious Diseases, Enzyme Deficiencies, in vitro Diagnostics, and Radiotherapeutics

Peer-Reviewed COVID

Pajon R, Paila YD, Girard B, Dixon G, Kacena K, et al. Initial analysis of viral dynamics and circulating viral variants during the mRNA-1273 Phase 3 COVE trial. Nat Med 2022: 1- 17.

Peer-Reviewed Oncology

Richardson K, Castillo JJ, Sarosiek S, Branagan AR, Flynn C, Meid KE, Gutine J, Liu X, Kofides A, Liu S, Wolf JL, Kacena KA. Identification of robust predictors for ibrutinib response by multi-omics in MYD88 mutated Waldenstrom Macroglobulinemia. Blood Advances. 2024: 1-13.

Peer-Reviewed Osteoarthritis

Bowes MA, Kacena K, Alabas OA, et al. Machine-learning, MRI bone shape and important clinical outcomes in osteoarthritis: data from the Osteoarthritis Initiative. Ann Rheum Dis 2021; 80:502–508.

Development Phases

Preclinical to Post-approval

Clinical Trial Designs

Application of innovative trial designs


2004-2006: Visiting FellowDepartment of Statistics, Harvard University, Cambridge, MA, USA

1998-1999: Postdoctoral Fellow, Department of Adult Infectious Disease, School of Medicine, Johns Hopkins University, Baltimore, MD, USA                                                                                         

1995-1998: PhD, Disease Control, International Health, School of Public Health, Johns Hopkins University, Baltimore, MD, USA (degree conferred 1999)

Coursework/dissertation equally weighted in biostatistics, epidemiology, and molecular biology (Advisor: Thomas C. Quinn, MS, MD)

1991-1995: BS, Double Major in Cellular and Molecular Biology, and Psychology, University of Michigan, Ann Arbor, MI, USA

Junior Year abroad: St. Edmund Hall, Oxford University, Oxford, England, U.K.


  • Eco-tourism (SCUBA, Snorkel, Land)….Especially with Tiger Sharks, Great Hammerheads, Humpback Whales, Orcas, Spotted Dolphins, Whale Sharks, Lemon Sharks, and Nurse Sharks
  • Languages, Swimming, Surfing, Vinyasa Yoga, Walking Jacky and Buddy