Getting the "Science of Clinical Trials" into the Data Scientist Role

Twenty-five years of biotechnology, microbiology and clinical trial data management. Areas of focus include recombinant, subunit, attenuated and whole cell bacterin and viral vaccines, cellular therapy, oncology, gout and biosimilar studies as well as monoclonal therapies. Significant exposure to global team leadership, project management and data operations functional management support for local and global team members, including clinical data coordinators, clinical data scientist leads and functional managers. Active member of Society of Clinical Data Management, working as conference co-chair for 2020 through 2023 annual general meetings as well as board of trustees member 2022 through 2024 working as academic committee liaison.

Richard Ittenbach, PhD, PSTAT is a Professor of Pediatrics, in the Division of Biostatistics and Epidemiology at Cincinnati Children’s Hospital and the University of Cincinnati College of Medicine. He is a professionally certified statistician through the American Statistical Association (PSTAT) and has been actively involved in biostatistics and clinical data management at the local and national levels for more than 20 years, with a particular interest clinical trials, data safety monitoring boards, and training the next generation of clinical data managers and clinical data scientists. Dr. Ittenbach remains active in the American Statistical Association, Society for Clinical Data Management, and American Association for the Advancement of Science. Dr. Ittenbach has served as a consultant to academe and industry, and has been a data management content area expert for the U.S. Department of Labor. Areas of research interest include mixed methods study designs as well as the development and refinement of pediatric measures for children with chronic and life-threatening illnesses. His articles have appeared in Academic Medicine, American Journal of Bioethics, Clinical and Translational Science, Medical Decision Making, and Journal for the Society of Clinical Data Management.

Alejandra Calcagno is a Principal Lead Clinical Data Manager for ICON with almost five years of Data Management (DM) experience. She has several diplomas in Medical Research and a bachelor´s degree in Fashion and Textile Design. As a Data Manager she has been involved in several protocols in different therapeutic areas such as Respiratory, Cardiovascular and Vaccines. During this time, she has also been a SME on several processes such as: Quality, Unblinded, Standards and DM processes.

Brian McCourt currently serves as Senior Director, Data and Knowledge Management at Duke Clinical Research Institute. He began his career as a study coordinator at Massachusetts General Hospital and has since held a variety of senior leadership roles spanning Clinical Data Management, Research Informatics and Technology areas at DCRI. His personal interests focus on the informatics methods and tools needed to operationalize the most complex industry and government research programs.

With over 25 years at Duke, he has been at the forefront of many strategic efforts to develop the infrastructure and capabilities needed to run demonstration projects and then scale-up capabilities for broader adoption of new best practices. Brian was central to standing up DCRI’s Supporting Open Access for Researchers (SOAR) initiative – the set of data preparation, hosting, approval and provisioning practices for sharing of research datasets. Today, in addition to overseeing data operations and staff for many research programs, he is helping drive the development and transition to a new cloud platform for research tools that includes data integration, hosting and visualization services.

Henry is a Vice President of Data Sciences at Medidata. His team's mission is to build scalable data science and engineering software services that are integrated into Medidata platform to accelerate the generation of actionable insights across the clinical development lifecycle. Previously, he has led and worked on data science teams across different functions at Janssen Pharmaceuticals, Johnson & Johnson Medical Device Companies and Roche Pharmaceuticals. Henry earned his B.S. in Electrical Engineering & Computer Science from UC Berkeley and Ph.D. in Biological & Medical Informatics from UCSF.