Professional Profile

Katherine Kacena is a Statistical Consultant with 15 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, Medical Devices, Autoimmune, Infectious Diseases, Chronic Pain, Enzyme Deficiencies, in vitro Diagnostics, and Radiotherapeutics

 

Education

2004-2006            Visiting Fellow, Department 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.


Current Work Experience

Katherine Kacena Consulting, Natick, MA, USA: President and Principal Statistical Consultant, 2012 - currently

Katherine Kacena Consulting provides statistical services in clinical trial design and simulation, statistical analyses, as a DMC statistician, and in communication with regulatory authorities, patient groups, investors, and as an expert witness in legal cases.


Prior Work Experience  

Aptiv Solutions, Southborough, MA, USA (formerly Averion International): Director, Biostatistics from 2009 to 2012 

Molecular Insight Pharmaceuticals, Cambridge, MA: Director of Biostatistics from 2007 to 2009 

ARIAD Pharmaceuticals, Inc., Cambridge, MA: Principal Biostatistician from 2006 to 2007 

Genzyme, Cambridge, MA: Principal Biostatistician from 2003 to 2006 (Sr. Biostatistician 2003-4) 

bioMérieux, Inc., Rockland, MA: Project Lead, Senior Staff Scientist, and Site Statistician from 1999-2003 

Becton Dickinson Microbiology Systems, Sparks, MD and Rockland, MA and the Johns Hopkins University School of Medicine, Division of Infectious Disease, Baltimore, MD: Postdoctoral Fellow in Molecular Diagnostics