Miganush Stepanians

Biography

Dr. Miganush Stepanians is the President and CEO of PROMETRIKA, which she founded in 2003. Dr. Stepanians has more than 25 years of experience in drug development, with a specific focus on biostatistics and data management. In addition to overall responsibility for the company’s scientific and operational activities, Dr. Stepanians is a practicing biostatistician, directly involved in study design and analysis, strategic product development planning, and commercialization support. Dr. Stepanians has designed the analyses for the Integrated Summaries of Efficacy and Safety for more than 10 successful marketing applications (NDAs; MAAs) and has presented on behalf of sponsors in meetings with FDA. She has particular expertise in challenging study design and analysis problems, including adaptive design trials, and has participated as a voting or non-voting member of a number of Independent Data Monitoring Committees. Prior to founding PROMETRIKA, Dr. Stepanians served as Director of Biostatistics and Data Management at Muro Pharmaceutical/Viatris, Inc., which she joined in 1993. In this capacity, Dr. Stepanians headed a department of 20 biostatisticians, programmers and data managers. As a member of several global project teams at Muro, Dr. Stepanians was a key contributor to the design of drug development programs and had primary oversight of statistical and data management activities. She had statistical oversight for the development and submission of three successful NDAs and interacted extensively with the FDA. Prior to joining Muro, Dr. Stepanians worked in the biostatistical arena for seven years, first at the New England Medical Center and then at Boston University’s Statistics and Consulting Unit, providing statistical services for a number of pharmaceutical companies in a wide range of indications. She has authored a number of journal articles. Dr. Stepanians received her Doctor of Philosophy degree in Statistics from Boston University in 1994. She received her Master of Science degree in Mathematics (Statistics) from Massachusetts Institute of Technology in 1984 and her Bachelor of Science degree in Mathematics and Psychology from Boston University in 1982.  

Research Interest

ROMETRIKA, LLC is a clinical research organization (CRO) supporting the biopharmaceutical and medical device industries since 2003. Based in Cambridge, Massachusetts, a biopharmaceutical hub, PROMETRIKA has provided more than a decade of experienced, professional support to local, national, and international clients. Our proximity to New England’s thriving biotechnology research environment has enabled us to establish strong, collaborative relationships with companies developing some of the most innovative and promising new therapies available. We offer full services in clinical operations, data management, biostatistics and programming, medical writing, pharmacovigilance, and regulatory submissions.