Decision Making in Clinical Development: How Statisticians are Impacting the Pharmaceutical Business
One aspect of the pharmaceutical industry thatstatisticians can continue to refine and influence is how data-drivendecisions are made. These decisions can be made from the earliestpoints in preclinical development through full commercializationof drugs. While data-driven decisions are common for a singlehypothesis, there are cases where additional information is needed todrive a decision. Using a clinical trial as motivation, we will discusswhere opportunities for statistical impact can befelt on decisions and where additional research could help in decisionmaking frameworks.
Dr. Jared Christensen is a Vice President and Head of Early Clinical Development Clinical AI/ML and Quantitative Sciences at Pfizer. He has a PhD in Biostatistics from Harvard University, and has worked in the industry for the last 17 years. Jared worked across early and late phase development in musculoskeletal and hematological diseases at Wyeth. While experienced in all phases of development, he has spent the majority of his career focused on early phase clinical trials, embedding decision making and objectivity into early clinical development plans. Jared has had roles of increasing responsibility for early clinical work across multiple research units at Pfizer including Inflammation and Immunology, Cardiovascular and Metabolic Diseases and Rare Disease. His areas of statistical interest include presentations and publications on topics such as dose-response modeling, estimands, small sample size trial design and missing data.