Frank Rockhold is Professor of Biostatistics and Bioinformatics at Duke University Medical Center and Duke Clinical Research Institute, and Professor of Biostatistics at Virginia Commonwealth University. His 50+ year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer and Senior Vice President of Global Clinical Safety and Pharmacovigilance. He has also held faculty appointments at six universities.
Dr. Rockhold is internationally recognized for his expertise in clinical trial design, safety and pharmacovigilance, public data disclosure, and scientific transparency. He has presented at FDA Advisory Committee meetings, Japanese and European regulatory agencies, National Academy of Science, Institute of Medicine, and the White House Office of Technology and Science. He is formerly an advisor to the Patient Centered Outcomes Research Institute as part of the Affordable Care Act, and an advisor to EMA
Dr. Rockhold is past President of the Society for Clinical Trials, past Chairman of the board for CDISC, and is currently Chairman of the Board of the Frontier Research Foundation. . He is coauthor of the ICH (International Council for Harmonization) E9 (Biostatistics), E10 (Control Groups) guidelines, CONSORT and SPIRIT Protocol guidelines. He has more than 250 publications in peer-reviewed scientific journals and more than 350 presentations and seminars at scientific symposia.
Frank has worked on more than 500 new molecular entities in every therapeutic area, including vaccines and consumer health, new indications, and combination products. He has been involved in the design or analysis of more than 2,000 clinical trials and served on and chaired more than 100 independent data monitoring committees.
Dr. Rockhold holds a BA in Statistics from The University of Connecticut, an ScM in Biostatistics from The Johns Hopkins University, and a PhD in Biostatistics from the Medical College of Virginia at Virginia Commonwealth University. He is an Elected Fellow of the American Statistical Association, the Society for Clinical Trials, and the Royal Statistical Society. He is an Accredited Professional Statistician, PStat®, and a Chartered Statistician, CStat.