Research Associate
Resume:
LEI HUA
**** ************ ***. ***. *-* Auburndale, MA 02466-1797
********@*****.***
EXPERIENCES
Harvard University, School of Public-Health Boston, MA
**/****-******* ******** Associate, Center for Biostatistics in AIDS Research (CBAR)
Senior Statistician, Statistical Data Analysis Center (SDAC) for AIDS CLINICAL TRIAL GROUP (ACTG)
SDAC Representative/Section Head in Hepatitis Transformative Science Group of the ACTG
Involved Projects:
Clinical Trials:
o A Phase II, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX® (Zoster Vaccine Live) in Human Immunodeficiency Virus (HIV)-1-Infected Adults on Potent Combination ART with Conserved Immune Function;
o A Randomized, Double-Blinded, Placebo-Controlled, Phase III Trial of the Quadrivalent HPV Vaccine to Prevent Anal Human Papillomavirus Infection in HIV-Infected (IND study);
o A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications (IND study);
o A Randomized Double-Blind Study Comparing Oseltamivir versus Placebo for the Treatment of Influenza in Low Risk Adults;
New Work Concept Sheet (NWCS):
o The Effect of Hepatitis C Treatment on Cardiovascular Risk Markers in HIV/Hepatitis C Co-infection;
o Point of Care Detection of Cryptococcal Antigen in Resource Limited Settings;
o Characterization of HCV RNA among HCV Seroconverters in ALLRT;
Data Analysis Concept Sheet (DACS): Association of HCV Co-infection with Virologic and Immunologic Responses to HAART in Treatment Naïve HIV Infected Subjects in Randomized Trials Conducted by ACTG;
Secondary Analysis: SLAM-C Study: Health related quality of life in long-term PEG-IFN/ribavirin treated HCV/HIV co-infected subjects.
Activities and Responsibilities:
Study Development:
o Drafted statistical sections and conducted sample size calculations for concept proposals;
o Drafted statistical consideration sections of the protocols and collaborated with other team members on protocol development;
o Drafted study monitoring plans;
o Facilitated the development and reviewed trial specific CRFs;
o Drafted statistical sections of randomization files and reviewed eligibility files used for the subject enrollment system;
o NWCS and DACS only: Identified specimen availability based on the ACTG database.
Study Monitor:
o Prepared interim trial safety, tolerability and toxicity reports;
o Defended the conduct of the trial during different safety reviews;
Study Related Analysis:
o Drafted Statistical Analysis Plans (SAP);
o Conducted analyses according to SAP;
o Prepared analysis reports;
o Collaborated with investigators on abstract, poster and manuscript preparation, provided statistical sections in manuscripts;
Study Motivated Research: Conducted methodological research on sample size determination for clinical trials with interval censored data and recurrent event data; implemented simulation studies comparing nonparametric analysis and semiparametric analysis approaches available in the literature.
THE UNIVERSITY OF IOWA Iowa City, IA
05/2007-08/2008 Research Assistant, Holden Comprehensive Cancer Center
Performed statistical analysis, generated tables, charts, graphs and listings and wrote analysis reports for various collaborative projects, ranging from simple mean comparison and logistic regressions, to survival analysis using nonparametric and semiparametric methods, to repeated measure analysis using generalized estimating equations and generalized linear mixed effect models;
Communicated with investigators regarding data analysis issues; determined appropriate analysis techniques for answering questions of interest; presented analysis results and provided written reports to investigating physicians;
Prepared research papers and manuscripts for publication, presentation at conferences and meetings and other written materials for funding agencies and others (e.g. NIH, FDA); assisted in grant applications;
Performed literature research on specified topics; evaluated related methods and trends and applied them in the data analysis as appropriate;
Developed method for documenting, and archiving statistical analysis programs, data sets, and results.
Summer 2008 Statistician, School of Social Work
Performed multivariate analysis to identify risk factors for psychosexual dysfunctions in abused children and adolescents;
Applied generalized estimating equation to account for the correlation between different aspects of the psychosexual dysfunctions;
Analyzed different datasets using SAS callable SUDAAN to account for complicated survey designs, as well as the repeated measurements across time;
Prepared statistical analysis reports.
12/2005-12/2006 Research Assistant, Iowa Registry for Congenital and Inherited Disorders
Performed logistic regressions to identify risk factors for cleft, and esophageal atresia;
Identified risk factors for still birth;
Managed data for Ducheness/Becker muscular dystrophy.
01-05/07, 01-12/05 Teaching Assistant, Department of Biostatistics
Led weekly discussion sections for Introduction to Biostatistics.
BEIJING HOSPITAL Beijing, CHINA
02/2001-10/2001 Clinic Intern
Rotated through Department of Internal Medicine, Surgery, Obstetrics & Gynae and Pediatrics;
EDUCATION
THE UNIVERSITY OF IOWA Iowa City, IA
05/2007-05/2010 PhD Biostatistics, received May 2010.
Thesis: Spline-Based Sieve Semiparametric Generalized Estimating Equation Method for Panel Count Data
01/2005-05/2007 MS Biostatistics, received May 2007.
08/2003-12/2004 Department of Biochemistry
09/1998-05/2003 PEKING UNIVERSITY HEALTH SCIENCE CENTER Beijing, CHINA
Medical Degree in Basic Medical Science, with honors, received July 2003.
HONORS
05/2010 Milford E. Barnes Award, College of Public-health, University of Iowa
08/2009 Strategic Initiative Fund, Department of Biostatistics, University of Iowa
06/2009 Graduate College Summer Fellowship, University of Iowa
04/2009 Dr. Eunice Beam Women in Science and Engineer (WISE) Travel Award, University of Iowa
03/2009 ENAR Student Paper Award, San Antonio, TX 2009
08/2008 Amgen Pre-doctoral Fellowship
05/2007 Student Member of Alpha Phi Chapter of the Delta Omega Honorary Society in Public Health
1998-2003 Peking University Health Science Center Scholarship
PUBLICATIONS AND PRESENTATIONS
Publications in Methodological Research
Ying Zhang, Lei Hua and Jian Huang (2010). A Spline-Based Semiparametric Maximum Likelihood Estimation Method for the Cox's Model with Interval-Censored Data. Scandinavian Journal of Statistics 37(2): 338-354.
Jian Huang, Ying Zhang and Lei Hua (2010). Consistent Variance Estimation in Semiparametric Regression Models with Applications to Interval-Censored Data. Interval Censored Data (edt. Sun, Jianguo).
http://www.public-health.uiowa.edu/biostat/research/documents/2008-3-Huang-Zhang-Hua.pdf
Lei Hua and Ying Zhang (2011). Spline-Based Sieve Semiparametric Generalized Estimating Equation Method for Panel Count Data. Biostatistics (Accepted).
Lei Hua and Ying Zhang (2011). Semiparametric Estimating Method for Over-dispersed Panel Count Data. Journal of the Royal Statistical Society: Series B (Submitted).
Publications in Collaborative Research
Melissa A. Fath, Anne R. Diers, Nukhet Aykin-Bums, Andrean L. Simons, Lei Hua and Douglas R. Spitz (2009). Mitochondrial electron transport chain blockers enhance 2-deoxy-D-glucose induced oxidative stress and cell killing in human colon carcinoma cells. Cancer Biology & Therapy 8(13): 1-9
Geraldine Jacobson, John Lammli, Gideon Zamba, Lei Hua, Michael J Goodheart (2009). Thromboembolic Events in Patients with Cervical Carcinoma: Incidence and Effect on Survival. Gynecologic Oncology 113(2): 240-244.
Easton, S., Coohey, C., O’Leary, P., Zhang, Y. & Hua, L. (2010). The Effect of Childhood Sexual Abuse on Psychosexual Functioning During Adulthood. Journal of Family Violence 26(1): 41-50.
Coohey, C., Renner, L., Hua, L., Zhang, Y. and Whitney, S. (2011) Academic Achievement Despite Child Maltreatment: A Longitudinal Study. Child Abuse and Neglect 35(9): 688-699.
Kemmer, N., Hua, L., Andersen, J., Chung, R., Butt, A. and Sherman, K. (2012) Health Related Quality of Life in Subjects with HCV/HIV Co-infection: Results of the SLAM-C Study. J. Viral Hept (Accepted)
CA Benson, L Hua, JW Andersen, JH Jiang, DR Bozzolo, K Bergstrom, PW Annunziato, SW Read, R Pollard, D Rusin, J Lennox for the ACTG A5247 Team (2012). ZOSTAVAX® is Generally Safe and Immunogenic in HIV-Infected Adults with CD4 Counts >200 Cells/µL Virologically Suppressed on ART: Results of a Phase 2, Randomized, Placebo-Controlled Trial. (In preparation)
Lei Hua, Camlin Tierney, Janet Andersen, Kimberly Hollabaugh, Marshall Glesby and Eric Daar (2012) Association of HCV/HIV Co-infection with Treatment Naïve HIV-infected Subjects’ Responses to ART. (In preparation)
Presentations
Lei Hua and Ying Zhang (2009). Spline-Based Sieve Semiparametric Generalized Estimating Equation Method for Panel Count Data.
March, 2009 ENAR conference, San Antonio, TX (Student paper award)
April, 2009 Amgen Inc., Thousand Oaks, CA
Lei Hua and Ying Zhang (2011). Semiparametric Estimating Method for Over-dispersed Panel Count Data. March, 2011 ENAR conference, Miami, FL. (Invited)
Kemmer, N., Hua, L., Andersen, J., Chung, R., Butt, A., Sherman, K. (2010). Health Related Quality of Life in Subjects with HCV/HIV Co-infection: Results of the SLAM-C Study. (Poster, CROI 2011).
Lei Hua (2011) Sample size considerations for interval censored data. CBAR/OpMAN section meeting.
Lei Hua (2011) HCV: Direct-acting Antiviral Agents (DAAs) currently in clinical trials. CBAR/Hepatitis TSG meeting
CA Benson, L Hua, JW Andersen, JH Jiang, DR Bozzolo, K Bergstrom, PW Annunziato, SW Read, R Pollard, D Rusin, J Lennox for the ACTG A5247 Team (2012). ZOSTAVAX® is Generally Safe and Immunogenic in HIV-Infected Adults with CD4 Counts >200 Cells/µL Virologically Suppressed on ART: Results of a Phase 2, Randomized, Placebo-Controlled Trial. (Oral, CROI 2012)
Lei Hua, Camlin Tierney, Janet Andersen, Kimberly Hollabaugh, Marshall Glesby and Eric Daar (2012) Association of HCV/HIV Co-infection with Treatment Naïve HIV-infected Subjects’ Responses to ART. (Poster, CROI 2012)
Professional Service
Member, American Statistical Association
Member, Institute of Mathematical Statistics
Member, International Biometric Society, the Eastern North American Region (ENAR, the Region)
Referee, Journal of Nonparametric Statistics
COMPUTER SKILLS
Operating Systems: UNIX, Windows
Statistical Software: SAS/SAS Macro, R/S-plus, Access, WinBUGS
Others: MS Office (Access, Excel, PowerPoint, Word)
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