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 (robert.wise@fda.hhs.gov)
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.