Violeta G. Hennessey, Ph.D.

Contact

Information

**** *** ****** ***** *** Cell: 323-***-****

Santa Monica, CA 90401 E-mail: ac3p51@r.postjobfree.com Qualifications More than 5 years’ experience in safety data analysis in clinical trials and post-marketing ob- servational studies. Experience with epidemiology and statistical methodology. Experience with manuscript development/publications. Experience with SAS for data management and statistical analysis.

Professional

Experience

WARNER BROTHERS HOME VIDEO, Burbank,CA

Sales Forecasting Manager 2015-present

Support a marketing group to forecast home video sales. Developed growth models for physical and digital sales. Developed a Bayesian approach to discrete choice models to assess price elas- ticity. Determine the appropriate forecasting methods, predictor variables and statistical model validation techniques to answer industry level questions from the marketing research group. AMGEN, Thousand Oaks, CA

Biostatistics Manager 2010-2015

Support global safety monitoring in clinical trials and observational studies. Lead statistician for a postmarketing pharmacoepidemiologic safety study using electronic healthcare databases in the US and in Europe. Collaborate with external academic investigators to develop statistical methodology to support safety assessments in clinical trials and observational studies. Provide statistical support for the Periodic Bene t-Risk Evaluation Report (PBRER) and the EU Sum- mary of Product Characteristic (SmPC). Review protocols, draft statistical analysis plans and table shell speci cations. Interact with clinicians, safety, and regulatory representatives. MD ANDERSON CANCER CENTER, Houston, TX

Graduate Research Assistant 2006-2010

Provided statistical support for leading MD Anderson oncologist in ovarian cancer research, col- laborated with oncologist to develop a novel Bayesian approach for dose-response modeling and drug-drug interaction analysis for in vitro studies. Education Ph.D. in Biostatistics 2010

University of Texas Graduate School of Biomedical Research and MD Anderson Cancer Center, Houston, TX

Thesis : A Bayesian Approach to Dose-Response Assessment and Drug-Drug Interaction Anal- ysis: Application to Ovarian Cancer In Vitro Studies.

Advisor: Gary L., Rosner, ScD - Director of the Division of Biostatistics and Bioinformatics at Johns Hopkins University

M.S. in Applied Mathematics 2005

University of Nevada, Las Vegas, NV

Thesis : An investigation of the Kaplan-Meier upper con dence limit for the population mean from environmental samples with nondetects.

Advisor: Ashok K. Singh, Ph.D.

B.S. in Computer Science 2003

Texas State University, San Marcos, TX

1

Mechanical Engineering 1996-1999

The University of Texas, Austin, TX

Research

Interests

Bayesian statistics, high-dimensional propensity score matching to adjust for confounding, joint mod- eling of longitudinal disease progression and failure time process, Bayesian dose-response modeling and drug-drug interaction analysis

Computer Skills Statistical Packages: SAS, R, WinBUGS, TIBCO Spot re.

Others: LATEX

Achievements

Amgen Biostatistician Top Performer 2013

Co-author of a book chapter in Quantitative Evaluation of Safety in Drug Development Developed Bayesian methods for various applications including dose-response modeling, drug-drug interaction analysis, jointly modeling longitudinal disease progression and informative drop out with competing risks, sample size calculation for meta-analysis of multiple clinical trials and historical data. Biopharmaceutical Section Student Paper Award 2009 presented at the American Statistical Association at the Joint Statistical Meeting in Washington DC, 2009

Student Merit Award 2007

presented by Dose Response Specialty Group at the annual meeting of the Society for Risk Analysis, 2007

Publications Hennessey, V., Rosner, G.L., Bast Jr., R.C., Chen, M., (2010). A Bayesian approach to dose- response assessment and synergy and its application to in vitro dose-response studies. Biometrics 66:4. 1275-1283.

Chen, M., Lu, Z., Bornmann, W. G., Hennessey, V., Rosner, G. L., Yu, Y., Ahmed, A. A., Das, P., Liao, W.S., Washington, M.N., Bast Jr., R. C. (2011). Decitabine and suberoylanilide hydroxamic acid (SAHA) inhibit growth of ovarian cancer cell lines and xenografts while inducing expression of imprinted tumor suppressor genes, apoptosis, G2/M arrest, and autophagy. Cancer 117(19):4424-4438.

Ibrahim, J., Chen, M., Xia, H., Liu, T., Hennessey, V. (2014). Bayesian sequential meta-analysis design in evaluating cardiovascular risk in a new antidiabetic drug development program. Statistics in Medicine 33(9):1600-1618.

Ibrahim, J.G., Ming-Huei, C., Xia, H., Liu, T., Hennessey, V. (2014). Book Chapter. Bayesian Meta-Experimental Design for Evaluating Cardiovascular Risk in Quantitative Evaluation of Safety in Drug Development. Chapman and Hall/CRC Biostatistics Series. Papers in

preparation

Hennessey, V., Xue, F., Ma, Haijun, McMullan, T., Petraro, P. Matching on high-dimensional propensity score, key confounders and a hybrid of both to adjust for confounding for the comparison of the risk of osteonecrosis of the jaw and atypical femoral fracture between Prolia users and bispho- sphonate users in women with postmenopausal osteoporosis. Hennessey, V., Li, J., Li, Z., Huang, X., Chi, E., Ibrahim, J.G. A Bayesian joint model for longitudinal DAS28 scores and informative drop out with competing risks in a rheumatoid arthritis clinical trial.

Hennessey, V., Baladandayuthapani, V., and Rosner, G. L., Chen, M., Liao, W.S., Bast Jr., R. C. (2013). Bayesian I-splines for dose-response modeling and drug-drug interaction analysis. 2

Journal Referee

or Reviewer

Statistics in Medicine, Journal of Biopharmaceutical Statistics Conference

Presentations

Hennessey, V., Amgen, Fei Xue, Amgen, Haijun Ma, Amgen, Trevor McMullan, Amgen, Paul Pe- traro, Amgen. Postmarketing Pharmacoepidemiologic Safety Studies Using Electronic Health Care Databases: Matching Control Subjects to Resemble Treated Subjects. Joint Statistical Meeting, Boston, MA, 2014.

Hennessey, V., Li, J., Li, Z., Huang, X., Chi, E., Ibrahim, J.G.. A Bayesian joint model for longitudinal DAS28 scores and informative drop out with competing risks in a rheumatoid arthritis clinical trial. UCLA Biostatistics Statistical Forum, Los Angeles, CA, October, 2012. References Gary L. Rosner, ScD - Director of the Division of Biostatistics and Bioinformatics at Johns Hopkins University (contact information available upon request) Fei Xue, MD, SeD- Director at Amgen, Department of Epidemiology Center for Observational Research (contact information available upon request) Donatello Telesca, PhD- Assistant Professor, Department of Biostatistics UCLA (contact infor ma- tion available upon request)

Leon Novelo Luis, PhD- Assistant Professor, Department of Biostatistics University of Texas Health Science Center at Houston-School of Public of Health (contact information available upon request) 3

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