Christy Chuang-Stein, Ph.D.
Dr. Chuang-Stein, a Fellow of the American
Statistical Association since 1998, is Head of the Statistical
Research and Consulting Center at Pfizer. Dr. Chuang-Stein has
22 years of pharmaceutical industry experience. She serves on
the editorial boards of Pharmaceutical Statistics, Drug Information
Journal (DIJ), and Wiley Encyclopedia of Clinical Trials. Dr.
Chuang-Stein, currently an Advisor for the Biostatistics and Data
Management Technical Group of the Pharmaceutical Research and
Manufacturers of America (PhRMA), was the Group's Chair for years
2003-2004. She continues to serve on several working groups under
the auspices of PhRMA. She has over 100 publications, which include
2 books and several book chapters. Dr. Chuang-Stein has been an
NIH Special Emphasis Panel member since 1996. She participated
in the reviews of grant applications submitted to the National
Institute of Allergy and Infectious Diseases, contributing to
funding decisions at the national and the international levels.
Ralph D'Agostino, Sr., Ph.D.
Prof. D'Agostino is Professor of Mathematics/Statistics
and Public Health at Boston University, Director of the Statistics
and Consulting Unit and the Executive Director of the MA/PhD Program
in Biostatistics at Boston University, Executive Director of Statistics
and Data Management at Harvard Clinical Research Institute.
Prof. D'Agostino is a Fellow of the American Statistical Association
and the Cardiovascular Epidemiology Council of the American Heart
Association. He is a Special Government Employee to the United
States' Food and Drug Administration and has been affiliated with
the FDA's Center for Drugs Evaluation and Research since 1974
as an Expert Consultant to the Biometrics, Over-the-Counter Drugs,
Oncology Drugs, Cardiovascular-Renal Drugs and Gastrointestinal
Drugs Divisions. He is also a consultant to the Device Division.
Further, he has served on a number of Advisory Committees and
was the Chair of the Nonprescriptive Drugs Advisory Committee.
He has twice been the recipient of the FDA's Commissioner's Special
Citation (1981 and 1995).
Prof. D'Agostino has over 400 publications in peer reviewed journals
and is a co-author/editor of eight books: Factor Analysis: An
Applied Approach, Goodness-of-Fit Techniques, Mathematical
Modeling: Applications in Emergency Health Services
, Tutorials in Biostatistics (2 volumes),
and Pharmaceutical Statistics Using
Prof. D'Agostino has served on the editorial boards of the American
Statistician, Journal of the American Statistical Association,
Biostatistica, and Statistics in Medicine. Presently, he is an
Editor of Statistics in Medicine, Associate Editor of American
Journal of Epidemiology and on the editorial board of the Journal
of Hypertension, Current Therapeutic Research and Health Services
and Outcomes Research Methodology. He is also an Editor of the
Wiley Encyclopedia of Clinical Trials.
Dr. Dmitrienko is Research Advisor,
Global Statistical Sciences at Eli Lilly and Company. He has worked
on early-stage clinical projects in a large number of therapeutic
areas and currently serves in a consulting/advisory role with
emphasis on innovative approaches in Phase I and Phase II development.
Dr. Dmitrienko has served on several PhRMA working groups (including the statistical
QT working group, multiple endpoints expert team, adaptive dose-ranging studies working group and adaptive design
working group). He has been actively involved
in biostatistical research and authored over 40 papers on statistical
sequential analysis, analysis of cardiac safety, multiple comparisons, group-sequential methods
and clinical trials.
Dr. Dmitrienko is a co-author/editor of two books: Analysis
of Clinical Trials Using SAS: A Practical Guide
with Geert Molenberghs, Christy Chuang-Stein and Walt Offen) and
Statistics Using SAS: A Practical Guide
(edited jointly with
Christy Chuang-Stein and Ralph D'Agostino). He serves on the editorial
board of the American Statistician, Statistics in Medicine and
the Wiley Encyclopedia of Clinical Trials.
Dr. Ferber studied Mathematics in Stuttgart
and Bochum (Germany). Before joining Sandoz Basle in 1984 he spent
10 years at the Medical School in Hannover and was involved in
the analysis of the clinical electroencephalogram. At the same
time he finished a doctoral thesis in Pattern Recognition at the
Faculty of Electrical Engineering of Hannover Technical University.
Since 1990 he has been working as a Statistician with Sandoz,
Innovex and later Novartis. He is currently Head of the Basle
Neuroscience as well as the Infectious Diseases, Transplantation
and Immunology Biostatistics Groups at Novartis. Since 2002 he
has also been involved in cardiac safety and has been a member
of the PhaRMA QT Statistical Experts Team and the QT ICH statistics
Dr. Scott Patterson is Senior Director, Vaccines
and Infectious Disease at Wyeth Research and Development. He previously
worked as Director of Statistical Science for Cardiovascular and
Metabolism Medicine Development at GlaxoSmithKline Pharmaceuticals
and Director for Clinical Pharmacology Statistics in Philadelphia
at SmithKline Beecham.
He is an expert on the design and statistical analysis of cross-over
and clinical pharmacology trials and coauthored the book Bioequivalence
and Statistics in Clinical Pharmacology
(written jointly with
Byron Jones) published by CRC Press, Chapman & Hall. He is an
editor for Pharmaceutical Statistics and is a cofounder and past
chair of the Pharmacometrics and Biostatistics Section of the
American Society of Clinical Pharmacology and Therapeutics. Scott
has over 10 years of statistical consulting and collaborative
experience in pharmaceutical research and development.
Dr. José Pinheiro is Director of Biostatistics
in Clinical Development and Medical Affairs at Novartis Pharmaceuticals,
where he has been since October 2001. He currently heads the Statistical
Methodology Group in the U.S., which is responsible for internal
consulting in biostatistics, leading various innovation projects
(e.g., adaptive designs), training, and methodological development.
He has been involved in the development and implementation of
innovative statistical methods for early and late phase clinical
trials across a wide range of therapeutic areas.
Dr. Pinheiro has served as a co-leader of the PhRMA PISC working
group on Adaptive Dose Ranging Studies and participated in the
PhRMA PISC working group on Adaptive Designs. He has been elected
to the Biostatistics and Data Management Technical Group for the
triennium 2007-2009. He was the co-chair for the 2006 ENAR meeting
of the International Biometric Society, is currently a member
of ENARs Regional Advisory Board (RAB), and has been elected
Secretary of ENAR for the 2007-2009 triennium. He is an associated
editor for the Biometrical Journal.
Dr. Pinheiro co-authored a book on the most widely used software
in S-PLUS and R for mixed-effects models (Mixed
Effects Models in S and S-Plus
), six book chapters, and over
35 refereed papers.
Dr. Arne Ring leads the team of Phase I/IIa
statistics at Boehringer Ingelheim Pharma, Germany. He received
his Masters degree in mathematics and biochemistry, and his PhD
in pharmacometrics. His major fields of interest are methodologies
around QT interval assessment, bioequivalence, as well as on pharmacodynamic
Dr. Frank Shen is Executive Director in Exploratory
Development, Global Biometric Sciences at Bristol-Myers Squibb.
He joined the pharmaceutical industry in 1989 and worked at Wyeth-Ayerst
Research as a Research statistician until 1993. He then joined
Biometrics Research group at Merck as a manager. Frank joined
Bristol-Myers Squibb (BMS) in 1996 as Associate Director and has
progressed with increasing responsibilities since then.
Dr. Shen has been named a Fellow of the American Statistical Association,
and elected as the 2004 President of the International Chinese
Statistical Association (ICSA). Frank is currently a member of
the Clinical Leadership Committee (CLC) of PhRMA and chairs the
Biostatistics and Data Management Technical Group under CLC that
leads biometric interactions between pharmaceutical industry and
Dr. Smith is Biostatistics Senior Manager
at Amgen Inc. He currently works in Medical Sciences and his work
focuses on early clinical development. He started working in the
pharmaceutical industry in 1996 for Eli Lilly and Company. He
spent nine years there focusing on clinical pharmacology and Phase
Dr. Smith's interests have focused on statistical methods to improve
the quality of clinical pharmacology research. Some particular
examples of Dr. Smith's interests include population pharmacokinetics
and pharmacodynamics, design and analysis of thorough QT studies,
analysis of dose proportionality, and bioequivalence.
Dr. Smith plays an active role with American Society of Clinical
Pharmacology and Therapeutics. He is currently an associate editor
for Clinical Pharmacology and Therapeutics.
Dr. Wiens is Director, Biometrics, at Gilead
Sciences. Prior to joining Gilead, his career included positions
at Myogen, Amgen, and Merck. He has been involved in clinical
trials for many therapeutic areas including cardiovascular, oncology
and infectious diseases. His research interests include noninferiority
trials and multiple comparisons.
Dr. Wiens currently serves as Chair of the Biopharmaceutical Section
of the American Statistical Association (2007). He also serves
on the editorial board of Statistics in Biopharmaceutical Research.