Position: Pharmacoepidemiology Fellowship Location: U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) Office of Biostatistics and Epidemiology (OBE) Division of Epidemiology (DE) Therapeutics and Blood Safety Branch (TBSB) Rockville, MD Qualification: Postgraduate degree in medicine, epidemiology, nursing, public health, or a related field Compensation: Commensurate with training and experience Point of contact: Robert P. Wise, MD, MPH ([email protected]) This 18-24 month fellowship (with possibility of renewal) offers the opportunity to work at the cutting edge of the science and regulation of biological products. The Therapeutics and Blood Safety Branch monitors the safety of a variety of biological products, including blood and blood products and human transplanted tissues. A particular priority involves the potential for transmission of infectious agents through tissue transplants. TBSB staff assess patterns among reports of suspected side effects or other evidence of possible new risks, evaluate options to clarify apparent associations, and communicate key findings to health professionals and consumers concerning safety and usage information, often through peerreviewed publications in medical literature and presentations at national meetings. The primary assignment of the selected fellow will be to work with large claims-based data sets from the Centers for Medicare & Medicaid Services (CMS). (“Claims” are generally requests for payments to health care providers for diagnostic, therapeutic, preventive, or other services or products.) The aims are to examine feasibility of using CMS data for studies of tissue graft utilization and safety. These tissue products include heart valves, skin, and bone. Available data may support studies to describe the frequency of various grafts, the body sites, the demographics, the comorbidities, the indications, and the adverse events associated with grafts. Stratification by variables of interest may also be possible. There is also potential to describe background rates of disease in the persons undergoing surgical procedures similar to grafts. Desirable skills for this position include familiarity with epidemiology, computer experience working in SAS, and good oral and written communication skills. Medical, nursing, or other clinical background would be an asset. For further information, please send a c.v. by e-mail to Dr. Wise.