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James J. Chen, Ph.D., Mathematical Statistician, Division of Biometry and Risk Assessment, FDA, National Center for Toxicological Research

Tsing-Hua University (Taiwan), B.S., 1970, Mathematics
The University of Pittsburgh, M.A., 1974, Mathematics
Iowa State University, M.S., 1976, Statistics
Iowa State University, Ph.D., 1978, Statistics

Experience:

  • 1978-1983: Assistant Research Scientist, University of Iowa, Iowa City, IA.
  • 1983-present: Mathematical Statistician, Division of Biometry and Risk Assessment, NCTR/FDA.
  • 1989-1993: Visiting Research Scientist (July, 1989; December, 1990; June, 1992; December 1993; August, 1998; and April, 2000), Institute of Statistical Science, Academia Sinica, Taiwan.
  • 1990 : Visiting scholar (October) at the China Medical University, Shenyang, P.R. of China.
  • 1995 : Visiting scholar (November) at the National Chiao Tung University, Taiwan.
  • 1990-1995: Central Arkansas Chapter of the American Statistical Association, Secretary-Treasurer, 1990; President, 1991; Chapter Representative 1992-1995.
  • 1994-present: Associate Editor, Communications in Statistics.
  • 1995-1997: NCTR Representative and member of Board of Directors of the FDA Statistical Asso.
  • 1999-2000: Chair, Biometrics Section, International Chinese Statistical Asso.

Honors:

  • Food and Drug Administration Commendable Service Award for research.
  • Public Health Service Special Recognition Award for research.
  • 1996 Fellow of the American of Statistical Association.
  • Food and Drug Administration Commendable Service Award.

Current Primary Research Interests:

  • Statistical modeling for quantitative risk assessment
  • Statistical methodology development for the analysis of carcinogenesis, mutagenesis, and developmental toxicological experiments
  • Environmental mixtures.

Most Recent Publications:

  • Chen, J.J. Dose Response Modeling for Clustered Data. In Encyclopedia of Environmetrics. (L. Ryan ed.), John Wiley & Sons, Ltd., London, (to appear).
  • Chen, J.J. Statistics in Toxicology. In Advanced Medical Statistics. (J.Q. Fang and Y. Lu ed.), World Science Publishing Co., (to appear).
  • Chang, J.Y., Ahn, H., and Chen, J.J. Order-restricted dose-related trend tests. Statistics in Medicine, (to appear).
  • Kang, S-h, Kodell, R.L., and Chen, J.J. Incorporating model uncertainties along with data uncertainties in microbial risk assessment. Regulatory Toxicology and Pharmacology 31, 2000 (to appear).
  • Kodell, R.L., Young, J.F., Delongchamp, R.R., Turturro, A., Chen, J.J., Gaylor, D.W., Howard, P.C., and Zheng, Q. A mechanistic approach to modeling the risk of liver tumors in mice exposed to Fumonisin B1 in the diet. Food Additives and Contaminants, 2000 (to appear).
  • Chen, J.J., Tsong, Y., and Kang, S-h. Tests for equivalence and non-inferiority between two proportions. Drug Information Journal 34 , 569-57, 2000.
  • Chen, J.J., Lin, K.K., Huque, M., and Arani, R.B. Weighted P-Value adjustments for animal carcinogenicity trend test. Biometrics 56, 586-592, 2000.
  • Chang, J.Y., Ahn, H., and Chen, J.J. On sequential closed testing procedures for a comparison of dose group with a control. Communications in Statistics - Theory and Methods 29, 941-956, 2000.
  • Kodell, R.L., Lin, K.K., Thorn, B.T., and Chen, J.J. Bioassays of shortened duration for drugs: statistical implications. Toxicological Sciences, 55, 415-432, 2000.
  • Chen, J.J. Reproductive and Developmental studies. In Encyclopedia of Biopharmaceutical Statistics. (S. Chow ed.), Marcel Dekker, Inc., New York, 445-453, 2000.
  • Kang, S-h. and Chen, J.J. An approximate unconditional exact test of non-inferiority between two proportions. Statistics in Medicine, 19, 2089-2100, 2000.
  • Lee, J.C., Chen, D-T, Hung, H-N, and Chen, J.J.. Analysis of drug dissolution data. Statistics in Medicine 18, 799-814, 1999.
  • Gaylor, D.W., Kodell, R.L., Chen, J.J., and Krewski, D. A unified approach to risk characterization. Inhalation Toxicology, 101-104, 1999.
  • Kodell, R,L, Chen, J.J., Jackson, C.D., and Gaylor, D.W. Using short-term tests to predict carcinogenic activity in the long-term bioassay. Human and Ecological Risk Assessment 5, 427-443, 1999.
  • Gaylor, D.W., Kodell, R.L., Chen, J.J., and Krewski, D. A unified approach to risk assessment for cancer and noncancer endpoints based on benchmark doses and uncertainty/safety factor. Regulatory Toxicology and Pharmacology, 29 151-157, 1999.
  • Chen, J.J. and Kodell, R.L. A decision-tree strategy for combining diagnostic tests for prediction. Biometrical Journal 41, 235-250, 1999.
  • Hwang, J.H. and Chen, J.J. An evaluation on risk estimation procedure for mixture of carcinogens. Risk Analysis 19, 1071-1076, 1999.
  • Gaylor, D.W., Kodell, R.L., and Chen, J.J. Human cancer risk estimates are reduced when based on relative risk for common rodent tumors. Regulatory Toxicology and Pharmacology 30, 283-284, 1999.
  • Arami, Ramin and Chen, J.J. A power study of a sequential method of p-value adjustment for correlated continuous endpoints. Journal of Biopharmaceutical Statistics 8, 585-598, 1998.
  • Chen, J.J. Analysis of reproductive and developmental studies. In Design and Analysis of Animal Studies in Pharmaceutical Development. (S. Chow and L. Liu ed.), Marcel Dekker, Inc., 309-355, 1998.
  • Chen, J.J. P-value adjustment for multiple binary endpoints. Communications in Statistics - Theory and Methods 27, 2791-2806, 1998.

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