Project Manager

Zhong Yu (May)

Tel: 650-***-****

E-Mail: ****@*******.***

Summary of Qualifications

15+ years of experience in Clinical Trials as Sr. Statistical Consultant.

Extensive knowledge and experience in the therapeutic areas of: Oncology,

Cardiovascular, CNS, and HIV, Medical device and Diagnostic. In addition I

have an extensive medical background through a MD degree from China. Career

highlights include:

Clinical Protocol Design and Review

CRF Design/Review

Develop Statistical Analysis plan

TLGs shell specification and validation

Write Validating Document

TLGs Validating

Sample size calculation/Justification

FDA Deficiency Response

PK/PD Analysis/Validation

Work on NDA, sBLA, ISS, ISE... etc.

Create Analysis Data Set

Design SAS, Access. Database

Participate Investigator's Meeting

Biostatistics/Clinical Research Highlights

Project Support

Simultaneously handled multiple projects within multiple therapeutic areas.

Participated in each project team meeting and interacted with Medical

doctors, Clinical Scientists, Project Statisticians, and Data Managers.

Type: NDA, sBLA, ISS, ISE

Phase: Phase I - IV

PK/PD: Prepare PK/PD analysis derived data set for population

analysis, multiple

indication, answer the questions. Create PK/PD parameters by Proc

Univariate, Means, Summary (Basic Analysis)

Clinical Support

Clinical protocol design/review, test statistical method and population

calculation.

Participated with site selection and clinical budget.

Reviewed CRF design and participated with investigator meetings.

Designed and created test programs for FDA's questions with clinical

scientist.

Exposure with MedDRA, ICD9...etc.

Designed and created CSR (Clinical Study Report) and responded to Ad-hoc

requests from clinical scientist.

Statistical Support

Organized the domestic and international integrated summary of safety and

effectiveness (ISS/ISE).

Developed statistical analysis plan and prepared validating programs and

document.

TLG shell specification and validation based on the data collection and

derived data set structure.

Calculated or validated the statistical method based on the raw and derived

data set.

Knowledge of FDA/ICH guidelines, the software development life cycle, and

21 CFR Part 11 and other FDA regulations.

Program Support

Created analysis data sets and TLGs, provided validating programs and

responded to ad-hoc requests from medical professionals, FDA questions,

Data Management as well as prepared manuscripts and staff's presentation.

Interfaced with CRO and provided instructions and guidelines.

CDISC experience includes: design and create CDISC data set (SDTM, ADAM).

Experience with "Standardized Procedure" using multiple operating systems,

EDC company specific software & extensive macros.

Created patient profile for review.

Management & Supervision

Monitored project performance and timelines and provided input for

performance reviews.

Participated in staff recruitment/ hiring/training as well as supervised

Statisticians and Programmers, etc.

Employment History

1997 - Present, Sr. Biostatistic Consultant for Pharmaceutical/CRO

Companies

Novartis/Quantiles - [11.2013-06, 2014, CA. Home Based]

Sr. Biostatistician/Sr. Consultant - Biometric Group

Provide statistical expertise for clinical trials.

Working on one project with multiple trials (Phase III) for FDA meeting in

Cardiovascular area.

Worked on other two phase III studies as independent statistician.

Johnson and Johnson/Inventiv Health - [05.2013-09.2013, Los Angeles, CA]

Sr. Biostatistician/Sr. Consultant - Biometric Group

Provide statistical expertise for clinical trials. Provide clinical study

design, validate summary tables, data listings, and figures for clinical

trials. Develop analysis plans, table shells, programming and table

specifications. Responded for final delivery as Sr. reviewer.

Maxsit/PPD- [05.2012-04.2013, Metuchen, NJ]

Sr. Biostatistician/Sr. Consultant - Biometric Group

Provided statistical expertise to multiple pre-clinical and clinical

trials. Developed analysis plans, table shells, programming and table

specifications. Responded for final delivery as Sr. reviewer.

Successfully managed 9 pre-clinical projects and 3 clinical projects (8

studies):

Pre-Clinical Studies included: Acorda (Project: RSY2) / Boehringer(Project

:WIY2) / Acorda( Project: YGY2) / Affymax(Project:NHY2) / Celltrion(

Project: HOX2) / Medicines(Project:ONY2) / Roche(Project: LOY) /

Enobia(Project:MYY2) / Celltrion(Project:IOX2)

Clinical Studies included: Millennium (Oncology, Phase 3, prostate cancer)

/ Bayer(Pain, phase II-PhaseIII, 15771, 15772) / Seaside(CNS, Phase II-

Phase III, five studies)

Roche (RMS) - [09.2011-04.2012, Pleasanton, CA]

Sr. Biostatistician/Sr. Consultant - Biometric Group - Therapeutic Area:

Oncology/ Virology/Transplantation/Biomarker analysis

I was involved with HIV, HPV, HCV, MPX, CMV, EGF, Virology and Transplant

projects. Designed statistical strategies for clinical trials in support of

multi-study projects in conjunction with clinical research personnel.

Assisted in identifying those aspects of the experimental design that will

measure the effectiveness and utility of investigational Q-PCR tests.

Statistically analyzed and prepared written summaries of scientific and

clinical data. The main responsibility is FDA deficiency response for

Transplant (Liver) project.

Hong En Corporation - [12.2008 -08.2011, Palo Alto, CA]

CEO - Therapeutic Area: Oncology

Project management for clinical trials, summary of Statistical Reports,

etc

Reviewed and provided input for essential trial documents such as

Protocols, CRF, Data Management Plan (DMP), Statistical Analysis Plan

(SAP), etc... Applied procedure and rules from Programming SOP's and

Business Practices when developing programs and creating trial directories.

Performed other work related duties as assigned (ad-hoc etc.).

Sanofi-Aventis - [05.2007 - 11.2008, Malvern, PA]

Sr. Consultant, Biometric Group - Therapeutic Area: Oncology

Provided clinical study design, programming support by

generating/validating summary tables, data listings, and figures to

clinical trials for regulatory submission. Designed and validated ISS/ISE

and updated the final results.

InterMune - [09.2006 - 04.2007, Brisbane, CA]

Sr. Consultant, Biometric Group - Therapeutic Area: Idiopathic Pulmonary

Fibrosis (IPF, Lung disease)

Protocol development, sample size calculation and CRF review. Validated six

trails, ISS/ ISE and programming. Provided clinical study design,

programming support by generating/validating analysis datasets (SDTM and

ADaM), etc.

Genentech - [09.2005 - 08.2006, So. San Francisco, CA]

Sr. Consultant, Biometric Group - Therapeutic Area: Oncology

Provided statistical expertise to multiple clinical trials. Created

analysis data sets and TLGs (Tables/ Listings/Graphs), validated programs,

responded to ad-hoc request from Medical professionals, Data Management,

prepared manuscripts and staff's presentation. Validate TLGs, etc.

Corgentech - [03.2004 - 08.2005, So. San Francisco, CA]

Sr. Consultant, Biometric Group - Therapeutic Area: Cardiovascular/Medical

Device Company.

Provided statistical input into the design of clinical studies,

investigational plans, Case Report Forms, database setup, edit checks, and

clinical reports. Developed statistical analysis plans, TLGs

(Tables/Listings/Graphs) specifications. Validated statistical analyses of

studies or multiple studies, including statistical review of derivations

and analyses for anti-sense DNA coated in a medical device that was

implanted in patients for the prevention of coronary artery bypass graft

(CABG) failure.

Genentech - [06.2003 - 03.2004, So. San Francisco, CA]

Sr. Consultant, Biometric Group - Therapeutic Area: Oncology

Created analysis data sets and TLGs (Tables/Listings/Graphs), validated

programs, responded to ad-hoc request from Medical professionals, Data

Management, prepared manuscripts and staff's presentation. Validated TLGs,

etc.

Purdue Pharmaceutical Company - [10.2002 - 05.2003, Stamford, CT]

Sr. Consultant, Biometric Group - Therapeutic area: Pain

Provided statistical contributions, authored and provided quality control

for study concept documents, protocols, randomization specifications,

statistical analysis plans, TLGs (Tables/Listings/Graphs) specifications,

endpoint derivation specifications, submission data file specifications,

protocol deviations, analyses, clinical study reports, etc. Completed

statistical analyses for study or multiple studies including: statistical

review of derivations and analyses for twenty-four trials pooled with ten

years period. Responded to FDA questions with Medical doctors.

Novartis- [09.2000 - 10.2002, East Hanover, NJ]

Scientific Analyst (Fulltime), Biometric Group - Therapeutic Area:

Oncology (Zometa), Cardiovascular (Devon), CNS

Provided statistical feedback and reviewed statistical deliverables

to meet the requirements of internal and external clients. Coordinated

and/or developed Statistical Analysis Plans (SAP), mock-up tables,

programming and derived dataset specifications. Protocol development which

included: trial design, randomization, sample size calculation, statistical

methods, defining study objectives and parameters. Wrote the statistical

section of the Clinical Study Report (CSR) and collaborated with the

Medical Writer to preparing the integrated CSR. Perform QC of TLG's and

derived datasets. Programmed derived datasets and Tables, Listings and

Graphs (TLGs), performed data review and statistical analysis. Collaborated

with Data Management by reviewing DMPs, CRFs and edit check specifications.

Eli Lilly-[10.1999 - 08.2000, Indianapolis, IN]

Statistician (Fulltime), Biometric Group - Therapeutic Area: CNS,

Oncology

TLGs validation, CRF design/review, develop SAP, PK/PD analysis, etc

Biostatistic Units (CRO)-[ 12.1997 - 09.1999, Birmingham, AL]

Project Manager (Fulltime), Biometric Group - Therapeutic Area: HIV,

Oncology

Supported projects for Gilead HIV trials and Pfizer's oncology phase

IV trials.

1992 -1996 Academic employment

University Alabama at Birmingham

School of public health Birmingham, AL

09.1995 - 08.1996

Epidemiology - (Full Time)

Department of Information Birmingham, AL

09.1992 - 09.1995

System and data analysis - (Part Time)

Education & Training

University of Alabama at Birmingham (UAB)

Master in Biostatistics and Epidemiology 1995

China Medical University, China

Medical Doctorate September, 1991

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