Curriculum Vitae

Dr. Balakrishna Hosmane

Northern Illinois University Division of Statistics

Associate Professor and Director of Statistical Consulting Services

PERSONAL DATA

Address:

Office: Division of Statistics

Northern Illinois University

DeKalb, IL 60115

(815) 753 – 6858

Home: 555 Fox Hollow

DeKalb, IL 60115

(815) 748 – 3561

Email: bala at math.niu.edu

EDUCATION:
Date	Degree	Institution	Location	Major
1983	Ph.D.	University of Kentucky	Lexington, KY	Statistics
1980	M.S.	University of Kentucky	Lexington, KY	Statistics
1976	M.A.	SUNY at Albany	Albany, NY	Mathematics
1972	M.Sc.	Karnatak University	Dharwar, INDIA	Mathematics
1970	B.Sc.	Karnatak University	Dharwar, INDIA	Physics & Mathematics

AREAS OF SPECIALIZATION:

Discrete Multivariate Analysis, Linear Models, Statistical Computing, Clinical Trials Methodology

PROFESSIONAL EXPERIENCE:
1989 – Present	Associate Professor [Tenured]	Northern Illinois University
1991 (Spring)	Visiting Associate Professor	Indian Statistical Institute, Bangalore
1983 – 89	Assistant Professor	Northern Illinois University
1982 – 83	Instructor	Department of Statistics, University of Kentucky
1978 – 82	Graduate Assistant	Department of Statistics, University of Kentucky
1974 – 78	Graduate Assistant	Dept of Mathematics, State University of New York at Albany

CONSULTING EXPERIENCE:
2005	Director of Statistical Consulting Services Northern Illinois University
1994 – 2002	Consultant Statistical Consulting Center Northern Illinois University
1990 – Present	Statistical Consultant for Abbott Laboratories, IMPAX Laboratories, Takeda Pharmaceuticals, Haemoscope
		[Input in designing clinical trials including power and sample size estimation (e.g., thorough QT studies). Develop and implement new statistical methodology. Exploratory analyses of phase I data. PK/PD modeling using nonlinear mixed effects models.]
1989 – 90	Statistician for Abbott Laboratories
		[Prepared statistical report of clinical trials for anti-hypertensive drug. Analyzed clinical data for Benign Prostatic Hyperplasia studies as part of the 1991 NDA filing. Developed statistical techniques to analyze the incidence of adverse events to support market study of Hytrin.]
1988 – 89	Consultant Statistical Consulting Center Northern Illinois University
1988 (Summer)	Consultant, CHANCE Program, Northern Illinois University
		[Developed an interactive statistical package.]
1979 – 80	Consultant Kentucky Longevity Project University of Kentucky
		[Developed an interactive conversational research support system.]

EXPERIENCE IN TEACHING:

Doctoral Thesis Supervision

A. Calachan Molefe, “Tests for Misspecification in Binary Regression using Generalized Estimating Equations Approach”, Ph.D. Thesis, May 2002.

Master’s Theses Supervision

M. Quigley, “Comparison of the estimators of the parameters in simultaneous Equations model”, Master’s thesis, 1987.

P. Cavenee, “A comparison of power divergence statistics for testing hypotheses in three dimensional contingency tables”, Master’s thesis, 1989.

S. Krishnamurthy, “Statistical Inference for Cost-Effectiveness Ratios”, Master’s thesis, May 2001.

Peng Liu, “Simulation Approach to Assess the Performance of Information Criteria for Selecting Variance-Covariance Structure for Longitudinal Data”, Master’s thesis, June 2003.

Graduate Courses Taught

Categorical Data Analysis, Linear Models, Nonlinear Models, Regression Analysis, Regression Diagnostics, Design of Experiments, Sampling, Multivariate Analysis, Statistical Methods, Mathematical Statistics, Consulting Course, Pharmaceutical Statistics.

Undergraduate Courses Taught

Calculus I, II, and III for math majors, Linear Algebra, Introductory Statistics, Mathematical Statistics, Regression, Design of Experiments.

GRANTS AND AWARDS:
1992 – 2003	Abbott Laboratories Research Grant
1997	National Science Foundation Grant (SCREMS)
1988	National Science Foundation Grant (SCREMS)
1988 (Summer)	Grant for the Improvement of Undergraduate Education, Northern Illinois University
1984 (Summer)	Summer Research Grant, Northern Illinois University
1979 (Summer)	Fellowship, University of Kentucky
1974	Council of Scientific and Industrial Research Fellowship
1973-1974	Karnatak University Fellowship
1966 – 1972	National Merit Scholarship (India)

MEMBER IN PROFESSIONAL ORGANIZATIONS:

American Statistical Association, Institute of Mathematical Statistics, International Indian Statistical Association, Elected Member of Sigma Chi, Biometric Society

PUBLICATIONS:

Published:

1. A Simulation Study of Power in ‘Thorough’ QT/QTc Studies and a Normal Approximation for Planning Purposes (with Charles Locke), Accepted for Publication in Drug Information Journal. 2005

2. Using lower trophic level factors to predict outcomes in classical biological control of insect pests (with Gross, et. al), Accepted for Publication in Basic and Applied Ecology. 2005

3. Quality-of-Life: Design and Analyses Issues in Clinical Trials, Communications in Statistics, Theory and Methods, Vol 33, 2004, p.1429-1443.

4. QT Interval: Correction for Heart Rate, Submitted for publication (2003).

5. Test for misspecification of covariance structure in dependent binary regression using generalized estimating equations, submitted for publication (2003).

6. Test for misspecification of link in dependent binary regression using generalized estimating equations, Journal of Statistical Computation and Simulation (2005). Accepted for publication.

7. Atrasentan (ABT–627), An Endothelin-Receptor Antagonist for Refractory Adenocarcinomas: Safety and Pharmacokinetics (with Carr, et al.). J. Clinical Oncology. 20, 2002, 2171 – 2180.

8. Invited discussion on the paper entitled “Combining evidence on air pollution and daily mortality from the 20 largest U.S. cities: a hierarchical modeling strategy” (with S. Gupta). J. Royal Statistical Society, A163, 2000, p. 295.

9. Optimal Allocation of Patients in Titration to Fixed Dose Studies (with Gupta, Singh and Singh). Journal of Statistical Planning and Inference, Vol. 106, 2002, 215 – 223.

10. Analysis of adverse events in titration studies (with Lin, Olson, and Padley). Journal of Statistical Planning and Inference, Vol. 96, 2001, 129 – 142.

11. Quality-of-life: Statistical Validation and Analysis. Example from a clinical trial. (with Maurath and Manski) Handbook of Statistics, Vol. 17: Bio-Environmental and Public Health Statistics, Edited by C. R. Rao and P. K. Sen., 2000, 871 – 891.

12. Relationship between terazosin dose and blood pressure response in hypertensive patients (with R. Achari). The Journal of Clinical Pharmacology, Vol. 40, 2000, 1166 – 1172.

13. The Analysis of Grouped Survival Data Using Logistic Regression (with Gupta) Journal of the Indian Statistical Association, Vol. 38, 2000, 301 – 316.

14. Operations Safety: An assessment of a commercial aviation safety program (with K. McFadden), Journal of Operations Management, Vol. 19, 2001, 579 – 591.

15. Finite sample properties of van Elteren test (with L. Chung) Journal of Statistics and Computing. Vol 5, 1999, 19-30.

16. Effects of oral and intravenous terazosin and head-up tilt on blood pressure responses in hypertensive patients (with Achari et. al.). The Journal of Clinical Pharmacology, 1998, 38, 545 – 553.

17. Assessment of the Pharmacokinetic – Pharmacodynamic Interaction Between Terazosin and Finasteride (with Dr. Samara et. al.). The Journal of Clinical Pharmacology, Vol. 36, 1996, 1169 – 1178.

18. Bayesian Inference for Dose-Response Model with Dependent Binary Data (with Dr. Natarajan and Cao). Proceedings of the American Statistical Association, 1996.

19. Finite Sample Properties of van Elteren Test. Proceedings of the American Statistical Association (1994), Biopharmaceutical Section (with Shu and Morris).

20. Construction of the Flow Rate Nomogram Using Polynomial Regression. Computer Methods and Programs in Biomedicine, Vol. 39 (1993), 285 – 288 (with Maurath and McConnell).

21. Effect of Age and Dose on the Incidence of Adverse Events in the Treatment of Hypertension in Patients Receiving Terazosin. The Journal of Clinical Pharmacology, Vol. 32, No. 5, 1992, 434 – 443 (with Maurath et al.).

22. Antihypertensive and Metabolic Effects of Concomitant Administration of Terazosin and Methyclothiazide for the Treatment of Essential Hypertension. The Journal of Clinical Pharmacology, Vol. 32, No. 4, (1992), 351 – 359 (with Black, et al.)

23. The Weighted Least-Squares Approach to the Analysis of Grouped Survival Data Using Logistic Regression. Proceedings of the American Statistical Association (1990), Biopharmaceutical Section.

24. Smoothing of likelihood ratio statistic for equiprobable multinomial goodness of fit. (Abstract appeared in the Proceedings of the 75^th session of the Indian Science Congress, 1988) Annals of the Institute of Statistical Mathematics, Vol. 42, No. 1, (1990), 133 – 147.

25. Modifications of the minimum logit chi-squared in simple linear logistic regression, Biometrical Journal. 30 (1988), 925 – 929.

26. A comparison of power divergence statistics for testing hypotheses in three-dimensional contingency tables. Proceedings of the American Statistical Association, (1988) Stat. Computing Section, 344 – 349, (with P. Cavenee).

27. On a generalized Stein estimator of regression coefficients, Communications in Statistics – Theory and Methods, A17, No. 6 (1988), 1735 – 1740.

28. A Monte-Carlo comparison of adjusted maximum likelihood and minimum logit chi-squared estimators in logit analysis, Proceedings of the American Statistical Association, (1987). Stat. Computing Section, 424 – 428, (with Dr. A. Hua).

29. An empirical investigation of chi-square tests for the hypothesis of no three-factor Interaction in I x J x K contingency tables, Journal of Statistical Computation and Simulation, Vol. 28 (1987), 167 – 178.

30. On shrinkage estimation of the exponential location parameter, Communications In Statistics – Theory and Methods, A16, No. 9 (1987), 2623 – 2637. (with Dr. N. Ebrahimi).

31. Improved likelihood ratio test for multinomial goodness of fit, Communications in Statistics – Theory and Methods, A16, No. 11 (1987), 167 – 178.

32. On the adjusted Wald statistic for testing log-linear hypothesis in categorical data, Sankhya, Series B, Vol. 49 (1987), 199 – 217.

33. Some conditions for optimality of the almost unbiased estimators of regression Coefficients, Communications in Statistics – Theory and Methods, 1987, 16(6), 1725 – 1731.

34. Improved likelihood ratio tests and Pearson chi-square tests for independence in two dimensional contingency tables, Communication in Statistics – Theory and Methods, 15 (6), (1986), 1875 – 1888.

35. On the asymptotic bias and mean squared error of an improved estimator for coefficients in linear regression, Economics Letters, 21 (1986), 163 – 167.

36. Multicollinear effect in logistic regression, Proceedings of the American Statistical Association (1985), Stat. Computing Section, 396 – 399, (with Dr. A.T. Hua).

Unpublished:

Minitab Reference manual for Introductory Statistics.

On asymptotic Pitman nearness of estimators for coefficients in linear regression.

Smoothing of Wald statistics for log-linear hypotheses in categorical data.

On the mean squared error of the adjusted minimum logit chi-square estimator.

A note on the bias and moment matrix of the mixed regression estimator.

Analysis of Adverse Event Data Using A Grouped Survival Methodology (with D. Jordan and C. Maurath).

Work in Progress:

Non-inferiority Testing in Thorough QT/QTc Studies with Parallel Design.

Bayesian Inference for Dose-Response Model with Dependent Binary Data.

Statistical Models for Cost-Effectiveness Analysis Test for Misspecification of the Correlation Matrix in Dependent Binary Regression using GEE.

Test for Misspecification of the Link in Dependent Binary Regression using GEE.

Finite Sample Properties of Goodness-of-Fit Tests for GEE.

OTHER PROFESSIONAL INFORMATION:

Papers Presented at Meetings:

Statistical Issues in Designing Clinical Trials, Presented at the Symposium on Clinical Trials at Hydrabad, India, August 2005.

Using Simulation to Assess Sensitivity of Sample Size Estimates to Assumptions, Presented at the International Indian Statistical Association Meeting in Athens, Georgia, May 2004.

Drug Development Process in the US Pharmaceutical Industry, Presented at the University of Northern Iowa, June 2004.

Application of Nonlinear Mixed Effects Models in PK/PD Studies, Presented at Takeda Pharmaceuticals, September 2004.

Pharmacokinetics of Oral ABT-492 Are Similar in Male and Female Subjects, Presented (with Gustavson, et. al.) at the ICAAC meeting in Chicago, September 2003.

Pharmacokinetics and Safety of Multiple Dose of ABT-492, Presented (with Gustavson, et. al.) at the ICAAC meeting in Chicago, September 2003.

Assessment of Adverse Events in Titration Studies, Presented at the ASA meeting in San Francisco, CA, August 2003.

Quality-of-Life: Design and Analyses Issues in Clinical Trials, International Workshop on QOL in Environment, Vannes, France, November 2002.

Heart Rate Correction of QT Intervals, Northern Illinois Chapter of ASA, October 2002.

Test for misspecification of correlation matrix in dependent binary regression, International Conference in Statistics, Combinatorics and Related Areas, Wollongong, Australia, December 18 – 21, 2001.

DUI/DWI Program Effectiveness in Commercial Aviation, ASA Chapter meeting, Northbrook, March 2001.

Test for misspecification of link in dependent binary regression, International Indian Statistical Association Meeting, New Delhi, India, January 2001.

Analysis of Adverse Event Data, Invited talk at the Drug Information Association, Hilton Head, SC, March 1999.

Analysis of Dependent Binary Data, International Conference, Mysore, India, December 1998.

Analysis of Grouped Survival Data, International Indian Statistical Association Conference in Hamilton, Canada, October 1998.

Finite Sample Properties of Estimators in Linear Mixed Models, Great Lakes Symposium, Kalamazoo, Michigan, October 1998.

Questionnaire Validation and Analysis. Invited talk at International Reliability Conference, DeKalb, Illinois, May 1998.

Longitudinal Data Analysis, Discussant at NIU workshop, November 1997.

Bayesian Inference for dose-response model with dependent binary data. Presented at ASA meeting in Chicago, August 1996.

Pharmacokintetics and Pharmacodynamics of Terazosin in Hypertensive Patients (with Grannaman & Achani). Presented at the ASCPT meeting. March 1996.

Lack of Adverse Pharmacokinetic and Pharmacodynamic Interactions between Terazosin and Finasteride (joint with Achari and Grannaman, presented at the American Society for Clinical Pharmacology and Therapeutics, March 1995).

Finite Sample Properties of van Elteren Test (joint with Shu and Morris, contributed paper at the American Statistical Association meeting in Toronto, Canada, August 1994).

Quality-Of-Life Assessment from Efficacy and Safety Trials of Terazosin in Benign Prostatic Hyperplasia Patients (BPH) (joint with P. Deverka et al., contributed paper at American College of Clinical Pharmacology in Washington, D. C., September 1992).

Dose-Response Analysis of Blood Pressure Response from Clinical Trials (NONMEM conference in San Francisco, California, May 1992).

The Weighted Least-Squares Approach to the Analysis of Grouped Survival Data Using Logistic Regression (contributed paper at the American Statistical Association meeting held in Anaheim, California, August 1990).

Messy Data in Safety Analyses (Invited talk at the Midwest Biopharmaceutical Statistics workshop held in Muncie, Indiana, May 1990).

A comparison of power divergence statistics for testing hypotheses in three-dimensional contingency tables (joint with P. Cavenee, contributed paper at the American Statistical Association meeting in New Orleans, August 1998).

A Monte Carlo comparison of adjusted maximum likelihood and minimum logit chi-squared estimator in logit analysis (joint with Dr. Hua, contributed paper at the American Statistical Association meeting in San Francisco, California, August 1987).

Multicollinear effect in logistic regression (joint with Dr. Hua, contributed paper, American Statistical Association meeting in Las Vegas, Nevada, August 1985).

On the bias in efficient estimation and testing for log-linear models (joint with Professor Bhapkar, invited paper, Institute of Mathematical Statistics 187^th meeting in Orlando, Florida, on March 14, 1984).

Colloquium Talks

Non-inferiority Testing in Thorough QT/QTc Studies (September, 2005), Invited Talk at University of Illinois at Chicago and at NIU.

Heart Rate Correction of QT Intervals, Invited talk at University of Chicago (March 2002); Division of Statistics, NIU (April, 2002); Takeda Pharmaceuticals (November 2002).

Heart Rate Correction of QT Intervals, Invited talk at Abbott Laboratories, August 2001.

Association between ECG and plasma concentration, Invited talk at Drug Metabolism, Abbott Labs, May 2000.

Assessment of Steady State Using Plasma Concentration, Invited talk at Drug Metabolism, Abbott Labs, November 1999.

Quality-of-Life: Validation and Analysis. Invited talk at Frostburg State University, 1997.

Analysis of Adverse