Miganush Stepanians, PhD
President and CEO

Dr. Miganush Stepanians is the President and CEO of PROMETRIKA, which she founded in January 2003.  She has 20 years of experience in drug development with specific focus in the biostatistics and data management area. In addition to her overall responsibility for the company’s operations, Dr. Stepanians provides consultation to clients in strategic development planning, study design, and commercialization support. Dr. Stepanians   interacts with the FDA statisticians and other reviewers with respect to study design and statistical analysis issues involved in NDAs. She oversees the preparation of NDAs and other regulatory submissions to the FDA and European regulatory agencies.  Dr. Stepanians has extensive experience and specialized expertise in meta analysis, ISS development, design and analyses of studies with patient reported outcomes, and design and analyses of clinical trails in asthma and COPD, including specialized measurements of pulmonary function.

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 working on numerous clinical trials. As a member of several global project teams, Dr. Stepanians was a key contributor in the design of drug development programs with primary oversight of statistical and data management portions.   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 in Statistics from Boston University in 1994.  She received her Master of Science in Mathematics (Statistics) from Massachusetts Institute of Technology in 1984 and her Bachelor of Science in Mathematics and Psychology from Boston University in 1982.

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