Safety assessment is critical in drug development. As part of risk management, safety data should be continuously monitored and analyzed during clinical trials. Statistical graphics, as a powerful statistical analysis tool, can be used to display data and maximize the ability to detect any unexpected and unusual features.
In this free on-demand webcast, join Michael O'Connell, TIBCO Spotfire and Dr. Haijun Ma, Biostatistics Manager at Amgen, as they discuss Dr. Ma's experiences in monitoring and analyzing clinical trial safety data graphically with TIBCO Spotfire S+, with an emphasis on data collected in phase II and III studies. Dr. Ma also presents graphs that have been developed to better visualize different types of clinical trial safety data and facilitate safety signal detection.
About the Speakers
Dr. Haijun Ma is currently a Biostatistics Manager in the Global Safety and Independent Biostatistics group at Amgen Inc. Her research interests include Bayesian modeling, signal detection, statistical visualization methods, missing data and spatial statistics. Haijun holds a Bachelors degree in Spanish language and literature from Nanjing University, a M.S. in Statistics from Iowa State University, and a Ph.D. in Biostatistics from the University of Minnesota.
Michael O'Connell has been working in the medical device, diagnostics, pharmaceutical and biotech arena for the past 15 years. Dr. O'Connell's background and graduate work was in applied statistics and he has published more than 40 papers on statistical methods and life science applications including calibration, mixed models, and nonparametric regression. He has also written several statistical software packages and libraries using S-PLUS, R and SAS. Most recently he has been active in the development of tools for analysis and reporting of clinical and safety data. Dr. O'Connell holds a Bachelors degree in Science from the University of Sydney, a Masters degree in Statistics from the University of New South Wales and a Ph.D. in Statistics from North Carolina State University.