Statistical Analyst @ Led statistical programming support for multiple clinical projects across multiple therapeutic areas, including Pain, Central Nervous System (CNS), Endometriosis and Uterine Fibroids, etc. Worked with project team to provide lead efforts to determine project standards related to output design and statistical programming conventions and independently ensure they are appropriate to support project objectives. Served as the primary contact for project team, ensuring accuracy of database quality assurance checks and assessing data accuracy and consistency. Developing database checks for routine and non-routine situations. Participating in the development of standard data quality assurance tools. Was responsible for creating ADaM data sets for the project based on CDISC and project – level standards. Coached and reviewed contractor and junior-level colleague’s work. Independently managing projects assigned to the team. Monitoring performance of the team members and ensuring project timelines to be met with good-quality deliverables even under pressure. Effectively mentoring programming peers with regards to statistical programming practices, functional operations and compliance with training requirements. Demonstrated proficiency in interpreting Statistical Analysis Plan (SAP) and developing analysis data specifications. Responsible for creation and accuracy of derivation programs for routine and non-routine situations. Responsible for ensuring peer review has been completed for all derivation programs for assigned projects. Responsible for creation, accuracy, peer reviewing of data sets and programs for submission, and for monitoring regulatory guidance and industry best practices to formulate proposals for new functional standards for submission data sets and programs. Provided SAS programming support to the Humira Ulcerative Colitis FDA Advisory Board Meeting. Provided SAS programming support on CSR efficacy tables and graph, ISE tables for Duodopa NDA submission. From January 2012 to June 2014 (2 years 6 months) Statistician @ Provided statistical support for Pain VICODIN and ABT-110 studies. Collaborated with Data Management and medical team to support database set up or lock for both compounds studies. Ensuring clarity, accuracy and consistency of Case Report Forms , database definitions, and specifications for analysis data sets for individual studies. Developed SAS programs to perform statistical analyses of all efficacy endpoints. Provided support in planning and writing SAP. Provided timely writing of protocol statistical section and SAP. Provided statistical writing support for Pharmacodynamics analyses. Provided timely and comprehensive review of clinical study report (CSR). Provided statistical and programming support for HCV studies. Provided statistical programming support for Obesity SIBUTRAMINE SCOUT submission, CSR, position paper, briefing book, advisory meeting and regulatory agancies’s requests. From June 2009 to January 2012 (2 years 8 months) Associate Statistician II @ Provided programming and statistical support for VICODIN NDA submission and studies as lead programmer and statistician. Supervised other statistician involved with programming and validation for NDA. Defined and created analysis ready data set. Collaborated with data management for database review and support of VICODIN studies. Reviewed SAPs, Clinic study report and protocol. Provided support for commercialization. Provided rapid support for FDA information requests to support VICODIN NDA. From May 2007 to May 2009 (2 years 1 month) Associate Statistician @ Provided statistical support as need for ZEMPLAR sNDA submission. Generated and validated tables, listings and graphs for assigned projects. Contributed statistical expertise to review of ISS and ISE documents. From October 2005 to April 2007 (1 year 7 months) Statistician @ Developed SAS programs for statistical analyses of clinical trial data. Generated and validated tables, listings, and graph for assigned projects. Contributed statistical expertise in the review of CSRs. From July 2005 to September 2005 (3 months) Statistical Programmer @ Worked with statistician to meet with MDs, wrote statistics analysis programs for clinical research using SAS STAT to do t test, ANOVA, Logistic Regression, Linear Regression, Chi-Square test, Binomial test, WILCOXON Signed-Rank test, WILCOXON Rank-Sum test, Survival analysis etc. and interpret result to the investigator. Designed and Developed SAS macro by using SAS SQL and SAS MACRO to generate rtf tables of descriptive statistics directly from SAS procedures result. Performed data cleaning, merging, retrieval and produced graphs/charts of the data for basic and clinical research. Used SAS Functions, Developed and documented complex statistical program using SAS BASE (proc tabulate, proc report, proc print etc.), SAS ODS to generate Screening, Enrollment, Enrollment Category, Adverse Event Incidence, End of Study and Premature Study Drug Treatment Discontinuations with adverse event table for FDA Annual Report. Generated Screening and Randomization, Protocol-Scheduled visit completion, Subject Demographics, Baseline Multiple Sclerosis, Baseline Functional Status, Baseline MRI Summary, Prior treatment with MS-Related Therapies, Baseline Concomitant Disease, Classification of Adverse Event, Withdrawals from treatment or Study, Hematology Flags, Urinalysis Flags, Blood Chemistry Flags, Reasons for Screen Failures, Protocol Deviations by Category and Site and Study Drug Administered table for DSMC meeting. Performed data validation, joining, and retrieval using SAS base, SAS SQL for DSMC meeting report. Developed, wrote and documented statistical program using SAS Graph (proc gplot, proc gchart, proc greplay, annotated dataset etc.) and SAS Macro to produce plot /bar of lab test flagged data for DSMC meeting. Worked on interface from ORACLE database to SAS datasets. Passed SAS 8.2 and 9.0 BASE CERTIFICATION EXAM Therapeutic areas: Cardiology, genomics From August 2003 to July 2005 (2 years) Teaching Assistant @ Independently instructed an undergraduate course with full responsibility: giving lectures, assigning exams and homework, and evaluating students’ performance. Instructed computer lab for one graduate level Biostatistics course: using SAS (Proc univariate, means, ttest, anova, freq, plan, npar1way, glm, etc.) and some Splus. From August 2001 to May 2003 (1 year 10 months) OBGY @ Practiced out-patient and in-patient care. From July 1996 to June 1998 (2 years)

Master, Statistics @ University of Kentucky From 2001 to 2003 Bachelor’s Degree, Medicine @ Hunan Medical University From 1991 to 1996 Chaohui Wang is skilled in: Pharmaceutical Industry, Clinical Trials, Validation, FDA, Biotechnology, Clinical Development, Oncology, GMP, CRO, Sop, Lifesciences, Regulatory Affairs, GCP, Pharmaceutical Sales, Regulatory Submissions, GLP, Drug Development, Infectious Diseases, HPLC, Pharmacovigilance