Zhi (Rachael) Wen, Ph.D. in Statistics

Contact Information:

Division of Biostatistics, OBE/CBER/FDA

Phone: 301-***-**** (O), 919-***-**** (C); Email: tww2a2@r.postjobfree.com

Education:

Ph.D. Statistics, North Carolina State University (NCSU) December 2009

M.S. Optimization in Applied Mathematics, Southeast University, China April 2004

B.S. Computational Mathematics, Nanchang University, China July 2000

Current Position: Mathematical Statistician, FDA 02/2010-Present

Perform statistical reviews of pre-INDs, INDs, bioassay validation, and license applications for adequacy of design, analysis, inferences, and conclusions.

Provide statistical expertise to scientists and medical officers in the FDA and the regulated industry concerning statistical aspects of IND and BLA submissions.

Resolve routine and critical issues in the interpretation and application of regulations and policy related to the approval of biologics products.

Publications:

1. Wen, Z., Pollock, K.H., Nichols, J.D., and Waser, P.M. (2011), Augmenting super-population capture-recapture models with population assignment data, Biometrics, 67, 691-700.

2. Wen, Z., Nichols, J.D., Pollock, K.H., and Waser, P.M., A Capture- Recapture model augmented with genetic data (Under review, Manuscript available upon request ).

3. Wen, Z., Yang, H., and Anderson, S., Spline longitudinal models for efficacy analysis of islet transplantation (Under review, Manuscript available upon request).

4. Wen, Z., Yang, H., and Anderson, S., Using multistate survival models to assess the efficacy of islet cell transplantation (In preparation, Manuscript available upon request).

5. Wen, Z., Nichols, J.D., Pollock, K.H., and Waser, P.M., Multi-State super population capture-recapture models augmented with origination information (In preparation, Manuscript available upon request).

6. Wen, Z., Yang, H., and Anderson, S., How missing data affect the efficacy assessment of islet transplantation for type 1 diabetes (In preparation, Manuscript available upon request).

7. Wen, Z., Pollock, K.H., and Jones C., Population level tags and individual level tags to estimate survival and movement probabilities in multi-site capture-recapture models (In preparation, Manuscript available upon request).

8. Pollock, K.H. and Wen, Z. (2009), Analysis of the North Carolina hunter harvest mail survey 2007-2008. North Carolina Wildlife Resources Commission.

Professional Services:

Chair and co-organize an invited session “Adaptive Design in Vaccine Trials", ENAR, Washington, DC, April 2012

Chair and co-organize a topic contributed session “Dose Selection in Clinical Trials", JSM, San Diego, CA, July 2012

Presentations:

Augmenting superpopulation capture-recapture models with population assignment data, JSM, San Diego, July 2012

Joint longitudinal models and semi-Markov multistate survival models for efficacy analysis of islet transplantation, FDA, Rockville, MD, May 2012

Statistical issues in an adaptive phase II study, FDA, Rockville, MD, September 2011

Spline longitudinal models for efficacy analysis of islet transplantation, ENAR, Miami, FL, April 2011

Longitudinal models for islet cell transplantation, FDA, Rockville, MD, June 2010

A super population capture-recapture model augmented with population assignment procedure, ENAR, New Orleans, Louisiana, March 2010

Estimating fishing and natural mortality rates with hierarchical models, Patuxent Wildlife Research Center, USGS, Maryland, May 2009

Population level tags and individual level tags to estimate survival and movement probabilities in multi-site capture-recapture models, American Institute of Fishery Research Biologists Meeting, Ottawa, Canada, March 2008

Related Experience:

a) Mathematical Statistician, FDA 02/2010-Present

Develop joint models for longitudinal measurements and time-to-event outcomes to analyze the clinical outcomes of patients having received islet transplantation.

Develop semi-Markov models for censored data with multiple primary endpoints.

Choose optimal dose in clinical trials with multiple primary outcomes measured at multiple time points.

b) Research Assistant, NCSU, USGS, and Purdue University 06/2007-02/2010

Used resampling approach, mixture model, longitudinal data analysis, and Bayesian method to develop new statistical models to integrate genetic information into capture-recapture data as well as estimate demographic parameters which can not be estimated by existing models, collaborating with scientists from NCSU, USGS, and Purdue University.

Applied the new statistical models to kangaroo rat data set (2600 genotyped animals).

c) Research Assistant, NCSU and VIMS 08/2006-06/2007

Used both empirical and Bayesian approaches to develop novel hierarchical models to estimate patch-specific fishing and natural mortality.

Models are used as important tools by some ecologists to assess the effect of marine reserves on the conservation of important fisheries.

d) Research Assistant, Department of Applied Mathematics, CWRU 08/2004-08/2005

Modeled transmission and control of infectious diseases (e.g., HIV)

Statistical Consulting Experience:

Survey Analyst, North Carolina Wildlife Resources Commission 08/2007-01/2009

Designed the North Carolina Mail Hunter Harvest Survey of 2007-2008, which was conducted every three years, for a data frame of 482,588 individuals.

Analyzed the survey data with multiple imputation, categorical data analysis, regression analysis, and longitudinal data analysis.

The sampling methods, analyzing approaches, and SAS procedures of this project are used by North Carolina Wildlife Resources Commission for other surveys.

Skills:

Adept in using R, SAS (Procedures, IML, Macro), WinBUGS, and JMP to conduct simulation and real data analysis

Fortran, Matlab, Basic, Pascal, C, Mathematica, Geneclass2

Teaching Experience:

Teaching Assistant, Operations Research Program, NCSU 08/2005-05/2007

. Prepared lectures for professor and answered Ph.D. students' questions

. Helped first year Ph.D. students preparing Ph.D. Qualify Examination

Teaching Assistant, Department of Applied Mathematics, CWRU 08/2004-08/2005

. Taught an undergraduate-level course \Advanced Calculus".

Teaching Assistant, Department of Mathematics, Southeast University, China 2003

. Taught a graduate-level course \Linear Optimization".

Professional Memberships

American Statistical Association

References Available upon request

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