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August 31, 2012

Back to Her Nordic Roots: EmpiriStat's Dr. Close Delivers for ISCB 2012

EmpiriStat President and Principal Biostatistician, Dr. Nicole Close, took her industry-revered expertise and experience to beautiful Bergen, Norway for the 33rd annual conference of the International Society for Clinical Biostatistics (ISCB), August 19-23, 2012.

The ISCB was founded in 1978 to stimulate research into the principles and methodology used in the design and analysis of clinical research and to increase the relevance of statistical theory to the real world of clinical medicine.

The ISCB aims to:
• stimulate research on the biostatistical principles and methodology used in clinical research;
• increase the relevance of statistical theory to clinical medicine;
• promote high and harmonized standards of statistical practice;
• work with other societies and organizations in the advancement of biostatistics;
• promote better understanding of the use and interpretation of biostatistics by the general public, and by national and international organizations and agencies within the public and commercial sectors with an interest in, and/or responsibilities for, public health; and
• provide a common forum for clinicians and statisticians through meetings, seminars and publications.

This year's gathering provided a scientific forum for international exchange of theory, methods and applications of biostatistics in medical research and practice among clinicians, statisticians and members of other disciplines, such as epidemiologists, clinical chemists and clinical pharmacologists, working or interested in the field of clinical biostatistics (

During the conference, Dr. Close was one of two members newly appointed the ISCB's subcommittee Statistics in Regulatory Affairs (SiRA), making her the sole American on the subcommittee.  As part of their business this year, the group discussed statistical guidelines from drug licensing agencies such as the United States Food and Drug Administration (FDA) and the European Medicines Association (EMA).  SiIRA also unanimously approved a proposal that they extend the subcommittee's scope to statistical guidelines from health technology assessment agencies such as the National Institute for Health and Clinical Excellence (NICE) and Institute for Quality and Efficiency in Health Care (IQWiG).

Close also acted as the invited Chair for the Contributed Session on Clinical Trials I and provided an oral presentation for the Contributed Session on Clinical Trials II. “It was a great meeting this year and I am so very proud to be participating and serving on the Regulatory Committee for the Society providing reviews.  Even more, I couldn’t have asked for the meeting to being conducted in a more beautiful country than Norway.  It was made more special knowing that through a fun ancestry DNA test recently, more than 60% of my DNA comes from the Scandinavian countries.  No wonder I felt like I was home!” Close stated.

For more information on ISCB, please visit their site (  Membership is open to all interested individuals who share the Aims of the Society. 

EmpiriStat is a technologically-advanced, statistical group aimed at personalized collaboration for clinical research.  EmpiriStat also customizes workshops and trainings and brings those workshops and courses on site for organizations throughout the world.  For more information on the wide range of expertise offered by EmpiriStat or if your organization would like EmpiriStat to provide a customized onsite training program, please go to or contact EmpiriStat directly at:

EmpiriStat, Inc.
13694 Sam Hill Drive
Mount Airy, MD 21771
Tel:  866.935.STAT (7828)
Fax: 866.276.STAT (7828)
Email: [email protected]


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