Project Data

Chaofeng Liu

**** ********* *****, **** *********, IN 47906

Email: abhxfb@r.postjobfree.com

Phone: 765-***-****

Education

****-**** ****** **********, **** Lafayette

MBA. Executive, Krannert Graduate School of Management

1999-2002 University of California, Los Angeles

Ph.D. Department of Biostatistics, School of Public Health

Dissertation: Semi-parametric Additive Hazard Models for Randomly Censored Survival Data

Minor: Computational Biology

1998-1999 University of California, Davis

Ph.D. program in Division of Statistics

1992-1995 Peking University, Beijing, China

MS, Department of Probability and Statistics

1988-1992 Peking University, Beijing, China

BS, Department of Probability and Statistics

Professional Experience

2010 - PAREXEL International,

Director, Statistical Science

• Provide leadership and guidance as the statistical expert to PAREXEL and its

clients within several therapeutic areas (Autoimmune, Oncology, Diabetes, etc)

• Be accountable for all statistical aspects of clinical studies and submissions,

including quality, relevance to regulatory perspective, and scientific validity

• Act as key statistical consultant within company and for sponsors in strategic plan,

clinical study design, data collection and analysis, SOP development, clinical

operation, regulatory issues, etc

• Be responsible for project timeline planning, staffing and resource allocation

within several therapeutic area(s).

• Actively promote business development activities, market statistical capabilities so

as to acquire new business within the strategic plan

• Contribute to development of proposal documents and participate in proposal bid

defense meetings

• Represent PAREXEL at client marketing and technical meetings

• Proactively participate in and/or lead process/quality improvement initiatives

2008 - 2010 Forest Laboratories, Inc, New Jersey

Associate Director, Biostatistics

• Serve as the statistical leader for two compounds in Neuroscience therapeutic area,

Phase I - IV

• Contribute the strategic development plan and perform matrix management of

statistics project teams, planning and tracking project level activities and resources

• Provide statistical input on study design, perform statistical analysis, review study

report for clinical trials, ensuring that clinical development program meets

scientific, regulatory, quality, and commercialization requirements

• Respond to regulatory agency inquires, plan and manage submission activities

• Work on Due Diligence projects in Neuroscience, Diabetes and Oncology products

• Develop the Thorough QT study design standard

• Interact with external medical experts and vendors

• Supervise junior/senior statisticians

2006- 2008 Novartis Pharmaceuticals Corporation, East Hanover, New Jersey

Senior Principal Biostatistician

• Therapeutic area: Respiratory (COPD and Asthma), Phase III

• Served as leading clinical biostatistician in developing clinical trial design,

protocol, statistical analysis plan, monitoring study process, interacting with

external medical experts and outside vendors, writing study report, discussing

compound strategic development plan, answering health authority inquiries,

preparing NDA submission package

• Worked with a multi-function team in developing new efficacy and safety standard

clinical reporting shells (tables/listings/graphs)

• Developed a statistical methodology method for the unbalanced mixing

distribution clinical trial data and a stepwise gate-keeping procedure for a multiple

testing in seamless adaptive study design which combines phase II and III studies

Mentored new employees

2002-2006 Eli Lilly and Company, Indianapolis, Indiana

Senior Statistician (title: Research Scientist)

• Therapeutic area: Women’s health and Oncology, Phase III/IV

• Served as leading statistician in making clinical product post marketing

development strategic plan, conducting and managing post marketing clinical

studies and data-mining projects, responding to regulatory inquiries, preparing

launching materials, producing medical and promotional data disseminations

(presentations and publications)

• Served as leading clinical statistician in developing clinical trial design, protocol,

statistical analysis plan, setting time line, allocating resources, supervising the

supporting statisticians, arranging workload to programmers, monitoring study

process, conducting data lock, writing study report, and supporting NDA

submission

• Developed several methods for non-normal data, biased survival data, non-

inferiority trial to maximize the utility of existing data and limited resources

• Built a prototype of new study design, conducted six-sigma project, prepared

response to CHMP and ICH guidance, improved program review process

• Led a cross-functional team including analysts, statisticians, ITs and DMs on

piloting a new annual report process

• Interacted with external medical experts and vendors

• Managing supporting statisticians and programmers

• Participated in hiring process, mentored new employees, intern and guided

statistical analyst

2001 Center for Health Policy Research, University of California, Los Angeles

Statistician

• Project: California Health Insurance Survey and Current Population Survey

• Overseeing data collection by health service organizations, data cleaning,

analyzing, interpreting, reporting

• Supervising junior statisticians

• New methods development for analyzing complicated data

2000 Center for Community Health, University of California, Los Angeles

Statistician

• Project: Exposure of HIV on Adolescents study

• Data cleaning, analyzing, interpreting, reporting

• New methods development for analyzing complicated data

1995-1998 Department of Probability and Statistics, Peking University, Beijing

Assistant Professor

Supervisor of undergraduate students, lecturer of statistics core courses, research on

statistical methods for medical and survey data

Publication

Chaofeng Liu and Liang Li (2010)

Individual Correction Method of QT Interval in Through QT Studies using Measurement

Error Model. In preparation.

Chaofeng Liu, Jun Xie and Ying Zhang (2008)

Weighted Nonparametric Maximum Likelihood Estimate of a Mixing Distribution in

Nonrandomized Clinical Trials. Statistics in Medicine, pp. 5303-5319.

Chaofeng Liu, Wei Shen and Jun Xie (2007)

Nonparametric empirical Bayes method for comparison of treatment effects with

application to stress urinary incontinence data. Pharmaceutical Statistics, 10.1002/pst.264

Weinstein D. L., Cohen J. S., Liu C., Meadow E., etc (2006)

Duloxetine in the treatment of women with stress urinary incontinence: results from

DESIRE (Duloxetine Efficacy and Safety for Incontinence in Racial and Ethnic

populations). Current Medical Research and Opinion, 22, pp2121–2129

David L. Weinstein,Jay S. Cohen, Chaofeng Liu, etc., (2006)

Efficacy of Duloxetine in the Treatment of Diverse Women with Stress Urinary

Incontinence (SUI). Obstetrics & Gynecology 2006;107:S1

Jun Xie and Chaofeng Liu (2005)

Adjusted Kaplan-Meier estimator and log-rank test with inverse probability of treatment

weighting for survival data. Statistics in Medicine, pp3089-3110

Mallinckrodt CH, Watkin JG, Liu C, Wohlreich MM, Raskin J. (2005)

Duloxetine in the treatment of Major Depressive Disorder: A comparison of efficacy in

patients with and without melancholic features. BMC Psychiatry, 2005;5:1.

Chaofeng Liu, Suresh Siddhanti, Eric Meadows and David Muram (2004)

Efficacy of blinded and open-label treatment of stress urinary incontinence (SUI) with

duloxetine. Journal of Pelvic Medicine & Surgery. 10 Supplement 1:S56

SAS System, SAS/ETS (1998); SAS System, SAS/STAT (1997);

SAS System, Base SAS (1997)

Co-editor, Chinese version SAS Manual, China Statistics Publishing House

Zhongjie Xie and Chaofeng Liu (1995)

Comparisons of Several Statistical Prediction Methods. The fifth Japan-China Symposium

on Statistics. pp316-324

Activity

2010 Adjunct Professor, Statistics Department of Purdue University, West Lafayette, IN.

2006 Organizer and Chair of Invited Paper Session on Survival Analysis with Pharmaceutical

Applications, Joint Statistics Meeting, ASA (08, 2006).

Organizer and Chair of Contributed Session on Current Development in Survival Analysis,

2004

ICSA Conference

1996 Supervisor of Survey Team (collaborated with Gallup Company)

Peking University, Beijing

Honors and Awards

2001-2002 Chancellor Dissertation Fellowship, University of California, Los Angeles

2000 Samuel J. Tibbitts Fellowship, University of California, Los Angeles

1997 Outstanding Teacher Award, Peking University, Beijing

1994 Young Scientist Award, Peking University, Beijing

1994 Excellent Student Paper Award, Peking University, Beijing

1992-1993 GuangHua Fellowship, Peking University, Beijing

1990-1991 Outstanding Student Fellowship, Peking University, Beijing

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