MARK YANG CHANG, PhD
Adjunct Professor, Biostatistics - Boston University School of Public Health
Biography
Mark Chang, PhD, is a fellow of the American Statistical Association and an adjunct professor of Biostatistics at Boston University. He is a co-founder of the International Society for Biopharmaceutical Statistics, co-chair of the Biotechnology Industry Organization (BIO) Adaptive Design Working Group, and a member of the Multiregional Clinical Trial (MRCT) Expert Group.
Dr. Chang received his Ph.D. in Civil Engineering and his Masters of Science in Biostatistics at the University of Massachusetts in Amherst, MA. He also received his Masters of Science and Bachelors of Science degrees at Hohai University in Nanjing, China.
Dr. Chang applies his 20 years of experience as a statistician at both biopharmaceutical firms and CROs to excel in his role as a strategic statistical consultant at Veristat. He is experienced with NDA submissions and working collaboratively with regulatory agencies throughout the clinical trial and submission process. Dr. Chang is also an adaptive design expert, having published 8 books on biostatistics and adaptive clinical trial designs.
Education
- University of Massachusetts Amherst, PhD Field of Study: Civil Engineering
- University of Massachusetts Amherst, MS Field of Study: Biostatistics
Publications
- Published on 1/1/2018
Balser J, Chang M, Bliss R. Interpreting the Regulatory Perspective on Adaptive Designs. Statistics in Biopharmaceutical Research. 2018.
- Published on 4/1/2017
Quan H, Mao X, Tanaka Y, Chang M. Example-based illustrations of design, conduct, analysis and result interpretation of multi-regional clinical trials. Contemporary clinical trials. 2017.
- Published on 3/13/2017
Teng Z, Chen YF, Chang M. Unified additional requirement in consideration of regional approval for multiregional clinical trials. J Biopharm Stat. 2017; 27(6):903-917. PMID: 28287339.
Read At: PubMed
- Published on 11/1/2016
Ravathi A, Green S, Chang M, Lavalley MP. Systematic comparison of the statistical operating characteristics of various Phase I oncology designs. 2016.
- Published on 10/1/2016
Chang M. What Constitutes Science and Scientific Evidence. Educational and Psychological Measurement. 2016; 77(3).
- Published on 4/1/2016
Teng Z, Chang M. Multiregional Clinical Trials for Simultaneous Global New Drug Development, Editors: Joshua Chen, Hui Quan. Optimal Multiregional Clinical Trials. 2016; (10):113-128.
- Published on 4/1/2016
Teng Z, Chang M. Multiregional Clinical Trials for Simultaneous Global New Drug Development. Adaptive Multiregional Clinical Trials. 2016; 177-191.
- Published on 1/1/2016
Chang M, Deng X, Balser J. An Alpha-Exhaustive Multiple Testing Procedure. Current Research in Biostatistics. 2016; (6):30-41.
- Published on 5/26/2015
Wang J, Chang M, Menon S. Biomarker informed add-arm design for unimodal response. J Biopharm Stat. 2016; 26(4):694-711. PMID: 26010506.
Read At: PubMed
- Published on 2/1/2015
Chang M, Wang J. Trial Design and Analysis with Incomplete Paired Data . American Journal of Biostatistics . 2015; 6.
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