Resume Of Our Principal Statistician

CURRICULUM VITAE

Chao Wang, Ph.D.

e-mail: abqqop@r.postjobfree.com. Phone: 410-***-****

Summary

Experienced in establishing and managing a Biometrics (Biostatistics, Statistical Programming, Clinical Data Management, and Database Management) department, including budget forecast and management.

Submitted or reviewed 10 BLA/NDA as the primary sponsor statistician or as the primary FDA statistical reviewer.

Statistical expertise: group sequential trial design and futility analysis, non-inferiority design, missing data imputation, mixed effects models, and survival analysis.

Medical experience: oncology, analgesic/sedation, dermatology, immunology, nephrology, cardiac, and CNS.

Professional Experience

Jun 2011 - Present

President and Principal Statistician

Pharma Data Associates, LLC

Provide consultation to the biopharmaceutical industry in study design, sample size/power calculation, CRF design, statistical analysis plan, SAS programming, ISS/ISE, and FDA electronic submission data package.

Act as an independent statistician for data monitoring committees

Jan 2010 Jun 2011

Senior Director, Biometrics

Shionogi Inc., Florham Park, NJ

Created the Biometrics department and the infrastructure.

Forecasted the headcount and budget.

Recruited and managed the staff to provide support for the clinical development, medical affairs, manufacturing quality, and pharmacovigilance.

Reviewed and approved protocols, CSRs, and FDA submission documents.

Collaborated with the Japanese counterpart on the global standardizations.

Medical area: metabolic syndrome, Opioid-induced AEs, women s health, CNS, and hematology.

Oct 2009 Jan 2010

Executive Director, Biometrics

Abraxis BioScience, Boston, MA

Supported the budget forecast for new clinical studies.

Supported the review of in-licensing activities.

Oversaw the biostatistical support for the clinical development programs.

Medical area: oncology.

Mar 2008 May 2009

Senior Director, Biometrics

King Pharmaceuticals (legacy Alpharma Pharmaceuticals LLC), Piscataway, NJ

Created the Biometrics department and the infrastructure.

Provided input on project timelines and resource requirements. Forecasted the department budget.

Reviewed and approved study protocols and reports.

Successfully led and managed the preparation of the ISS and the statistical data package in CDISC and the FDA 1999 Guidance formats for the EMBEDA NDA resubmission. Assisted the preparation of the briefing book and Q&A for the FDA Advisory Committee meeting.

Medical area: pain/analgesics.

2003 2008

Senior Director, Biometrics

Director, Biostatistics

Eisai, Inc. (legacy MGI Pharma, Inc. 2005-2008 and legacy Guilford Pharmaceuticals, Inc. 2003-2005) Baltimore, MD

Created Biometrics department. Developed SOPs, procedures, and templates. Decided computer hardware and software. Set up vision and expectation for the department staff.

Responsible for the direction and operation of the Biometrics department, supporting 4 late phase/marketed products and 5 early to mid phase products. Made decisions for recruitment for in house needs vs. outsourcing opportunities.

Provided input to the management on project timelines and resource requirements. Forecasted and managed the department budget.

Championed the EDC data management system.

Led the Biometrics team for the clinical development of Lucedra. Spearheaded the ISS/ISE for 21 clinical trials with the design, analysis, and interpretation of the statistical tables. Interacted with the FDA eSubmission team and managed the preparation of the statistical part of the NDA submission in CDISC format.

Designed and actively negotiated with the FDA for the noninferiority and superiority trials for a cardiovascular drug.

Prepared and defended a regulatory submission in an Asian country.

Medical area: Sedation, CV, oncology, hematology, and CNS.

2001 2003

Mathematical Statistician

Center for Biologics Evaluation and Research (CBER)

The US Food and Drug Administration (FDA). Rockville, MD

Reviewed submissions for over 70 different Biologics License Applications (BLA), Investigational New Drugs (IND), and Investigational Device Exemptions (IDE). Recommended approval/no approval decisions for many BLAs and pivotal protocols. Represented the FDA Biostatistics at the advisory committee meetings.

Held meetings with sponsors at various stages to provide statistical input on study design, data analysis and interpretation, and regulatory guidance.

Represented Office of Biostatistics and Epidemiology in the CBER Review Management Coordinating Committee.

BLAs reviewed include Herceptin, Amavive, ReoPro, Xolair, and Enbrel.

Areas of review included oncologic, immunologic, CVS, ophthalmic, orthopedic, pulmonary, skin, and respiratory diseases treated with monoclonal antibodies, cytokines, gene therapies, recombinant growth factors, and fusion proteins.

1995 2001

Project Statistician (Manager II)

Senior Biostatistician II (Manager I)

Senior Biostatistician I (Associate Manager)

Biostatistician II

Amgen, Inc. Thousand Oaks, CA

Led the US biostatistics team for the development of ARANESP program. Responsibilities included phase 1-3b studies designs, protocols and CRF development, writing statistical analysis plans, conducting statistical analyses, coauthoring clinical study reports, performing ISS/ISE, and reviewing the statistical and clinical sections of the BLA and MAA submissions. The designs of studies included parallel comparison, crossover, non-inferiority, single- and multi-dose PK, and bioequivalence. Cooperated with the UK team on the resource, timing, standardization, review and other issues. Helped preparing briefing documents and participated pre-Phase 3 and pre-BLA submission meetings with the FDA.

Led the biostatistical support for the EPOGEN program. Responsibilities included writing statistical analysis plans, conducting analyses, and authoring statistical reports for clinical phase 2-3 studies, and working with investigators on the study designs, analyses, and publications for Amgen sponsored post-marketing studies.

Primary contributor to the pediatric sBLA for EPOGEN. This included analyzing and reporting individual studies, summarizing overall efficacy and safety, and reviewing the submission.

Revised the design of a group sequential. Presented interim analyses to the Data Monitoring Committee. Interacted with the FDA reviewers and the journal reviewers on the statistical interpretation of the results when the study was prematurely terminated.

Medical area: nephrology and CV.

1992 1995

Biostatistician

Allergan Inc. Irvine, CA

Responsible for the statistical aspects in several clinical development programs.

Contributed to several phase 3 studies for BOTOX and ALPHAGAN. Duties included CRF designs, statistical analyses for individual study reports, and overall summary reports.

Assisted the ISS/ISE for several NDA submissions including TAZORAC.

Medical area: ophthalmology, dermatology, and CNS.

Education

1992, 1990

Ph.D. and M.S., Biostatistics

School of Public Health, University of California, Los Angeles

1986

M.S., Experimental Neurobiology

Shanghai Brain Research Institute, Academia, Sinica

Professional Training (Select List of Post Graduate Courses)

FDA Reviewer Training

Group Sequential Trial Designs

Winning at FDA a Strategic Guide

Survival Analysis for Recurrent Events

NDA Preparation an Overview

Linear and Nonlinear Mixed Effects Model

Role of Data Safety Monitoring Board

Bayesian Statistics

Drug Laws and Regulations

Principles of Clinical Pharmacology

CDISC ADaM

Adaptive Clinical Trials Designs

Effective Negotiation Skills

Analysis of Repeated Categorical Data

Awards

Food and Drug Administration (FDA) 2003 Outstanding Service Award for Excellence in Statistical Computing Involving Complex Statistical Problems and Graphical Presentation of Clinical Data.

FDA Center for Drug Evaluation and Research (CDER) 2004 Group Award for Exceptional Performance in the Priority Review of the Etanercept Supplemental Applications, the First Biological Therapy for Ankylosing Spondylitis.

FDA Center for Biologics Evaluation and Research (CBER) 2003 Reward & Recognition for Producing a Graphics Oriented Patient Profile to Facilitate Clinical Review of Safety Data.

FDA CBER 2002 Reward & Recognition for Performing Excellent Review Work and Highly Successful Collaboration with Clinical Reviewers on the BLA Treatment for Psoriasis.

FDA CBER 2001 Reward & Recognition for Carrying Additional Workload and Performing Outstanding Statistical Analysis Work.

One Guilford and three Amgen Excellent Service Awards.

Professional Affiliations

Drug Information Association

American Statistical Association

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