Melanie Quintana, Ph.D.
Vice President & Senior Statistical Scientist
Dr. Melanie Quintana is Vice President & Senior Statistical Scientist at Berry Consultants, where she provides strategic and technical leadership in the design of Bayesian adaptive clinical trials across complex development programs. Her work focuses on translating advanced statistical methods into practical, decision-focused trial designs, particularly in rare and progressive diseases and platform trial settings.
Dr. Quintana has played a key leadership role in numerous high-impact programs, including the HEALEY ALS Platform Trial, and has led disease progression modeling and clinical trial simulation efforts across conditions such as GNE Myopathy, Duchenne muscular dystrophy, Fibrodysplasia Ossificans Progressiva, Alzheimer’s disease, and Frontotemporal Dementia. Her approach integrates Bayesian methodology, simulation-based evaluation, and disease-specific data to support clear, well-informed development decisions.
Dr. Quintana has extensive experience supporting sponsor–regulator interactions for innovative clinical trial designs, including adaptive and platform trials in rare and progressive diseases. She works closely with sponsors to develop clearly articulated design rationales, pre-specified analysis strategies, and simulation-based evaluations of operating characteristics that facilitate productive regulatory dialogue. Her experience spans advisory meetings, protocol reviews, and ongoing regulatory engagement, with a focus on aligning innovative methodology with practical development and decision-making needs.
Prior to joining Berry Consultants, Dr. Quintana earned her Ph.D. in Statistics from Duke University and completed a postdoctoral fellowship in Biostatistics at the University of Southern California, where she collaborated on large-scale consortium studies addressing complex disease risk. These experiences shaped her long-standing interest in Bayesian approaches for solving challenging clinical and research questions.
As Vice President at Berry, Dr. Quintana leads a team of more than 30 scientists contributing to the design of over 100+ clinical trials annually. She provides methodological guidance and strategic oversight across trial design and analysis planning, fosters a collaborative and innovative team culture, and is deeply engaged in mentoring and professional dissemination. She has delivered more than 50 invited presentations and workshops, has more than 30 scientific publications, serves on Data and Safety Monitoring Boards, grant review panels, and in advisory roles to industry sponsors. Across her work, Dr. Quintana combines methodological innovation with applied impact to improve clinical development and patient outcomes.