Miganush Stepanians, PhD, is the President and CEO of a full-service CRO based in Cambridge, Massachusetts, US, since 2003. Miganush has more than 25 years of experience in drug development, with a specific focus on biostatistics and data management. She has particular expertise in challenging study design and analysis problems, including adaptive design trials and rare disease research. Miganush has designed the analyses for the Integrated Summaries of Efficacy and Safety for more than 15 marketing applications (NDAs/BLAs; MAAs) and has presented on behalf of sponsors in meetings with FDA. She participates as a voting or non-voting member of a number of Independent Data Monitoring Committees (IDMCs) for sponsors’ trials. Prior to entering the biopharmaceutical industry, Miganush worked in the biostatistical arena for seven years, first at the New England Medical Center (Boston) 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. Miganush received her Doctor of Philosophy degree in Statistics from Boston University, her Master of Science degree in Mathematics (Statistics) from Massachusetts Institute of Technology, and her Bachelor of Science degree in Mathematics and Psychology from Boston University. Miganush and her team became members of AICROS in 2018 and are responsible for research activities in North America and Canada.