Mark Chang, PhD
Adjunct Professor
Boston University School of Public Health

PhD, University of Massachusetts Amherst
MS, University of Massachusetts Amherst

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.

Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Faculty can login to make corrections and additions.

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  1. Balser J, Chang M, Bliss R. Interpreting the Regulatory Perspective on Adaptive Designs. Statistics in Biopharmaceutical Research. 2018.
  2. 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.
  3. 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
  4. Ravathi A, Green S, Chang M, Lavalley MP. Systematic comparison of the statistical operating characteristics of various Phase I oncology designs. 2016.
  5. Chang M. What Constitutes Science and Scientific Evidence. Educational and Psychological Measurement. 2016; 77(3).
  6. Teng Z, Chang M. Multiregional Clinical Trials for Simultaneous Global New Drug Development. Adaptive Multiregional Clinical Trials. 2016; 177-191.
  7. 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.
  8. Chang M, Deng X, Balser J. An Alpha-Exhaustive Multiple Testing Procedure. Current Research in Biostatistics. 2016; (6):30-41.
  9. Wang J, Chang M, Menon S. Biomarker informed add-arm design for unimodal response. J Biopharm Stat. 2016; 26(4):694-711.View Related Profiles. PMID: 26010506; DOI: 10.1080/10543406.2015.1052474;
  10. Chang M, Wang J. Trial Design and Analysis with Incomplete Paired Data . American Journal of Biostatistics . 2015; 6.
Showing 10 of 25 results. Show More

This graph shows the total number of publications by year, by first, middle/unknown, or last author.

Bar chart showing 25 publications over 11 distinct years, with a maximum of 5 publications in 2015 and 2016


In addition to these self-described keywords below, a list of MeSH based concepts is available here.

adaptive design
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