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Dr. Nicole Close – President and Principal Biostatistician, EmpiriStat

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Qualities: As founder, president, and principal biostatistician at EmpiriStat, Nicole is the driving force behind the company’s success. With an eternally optimistic outlook, a passion for hard work and detail, and a unique creativity and humor, Nicole inspires her team and clients alike to surpass expectations. She values a good work/life balance and encourages the same in her team—she is an avid International trainer in clinical trials, enjoys her advanced scuba certification, loves learning about new cultures and food while traveling, and doesn’t miss a game for her beloved Pittsburgh Steelers.

Role: Nicole serves as the senior biostatistician to EmpiriStat statisticians and statistical programmers. She provides guidance for regulatory submissions work, leadership for clinical development projects, and is directly responsible for the statistical integrity, adequacy, and accuracy of the clinical studies developed and produced by her colleagues.


  • Trained in Epidemiology and Biostatistics (Juniata College, Case Western Reserve University and The George Washington University)
  • More than 16 years of professional experience conducting and managing clinical trials and epidemiological research—including the management of coordinating centers and large-scale, multi-site data collection and statistical analysis activities
  • Board Member, Committee Chair, and workshop faculty member for a variety of professional organizations including the American Statistical Association (ASA), The Society for Clinical Trials (SCT), and the International Society for Clinical Biostatistics (ISCB). She is a peer reviewer for several organizations including the Congressionally Directed Medical Research Program (CDMRP), the National Institutes of Health (NIH), and the Health Resources and Services Administration (HRSA), as well as training members and serving on various Data and Safety Monitoring Boards
  • Founded EmpiriStat in 2008

Interview Air Date: July 21, 2012


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