Chris Barker, Ph.D.

Clinical Trial Biostatistician

ADDRESS

Home: *** ******** ******

San Carlos CA 94070

E-mail: abqsoh@r.postjobfree.com

C: 415-***-****

Accomplishments

Statistical consultant with Pharmaceutical and Medical Device Companies. Currently providing

statistical planning and analysis for oncology phase I 3+3 clinical trials. Prepared statistical

analyses for a Thorough QT study for Ceftaroline in Community Acquired Pneumonia.

Extensive hands-on experience in diverse aspects of drug development, including designing,

conducting and analyzing clinical trials, Phases, I, II, III, IV, Health Economics, and Outcomes

Research and statistical analyses for large Insurance claims databases and registries.

Statistical leader for the design, conduct and analysis of Phase II and III clinical studies leading to

successful worldwide registration of CELLCEPT for kidney transplantation and successful

negotiation with FDA and other regulatory agencies worldwide, in all phases of the transplant

development program and responding to questions at the successful advisory meeting. Prior

experience preparing analyses of Phase III trials included in the successful U.S. registration of

AMBIEN.

Diverse experience in multiple therapeutic areas, including cardiovascular, organ transplantation,

Parkinsons s disease, obesity, osteoporosis and cancers including breast, and colon.

CRO selection, oversight and verification of the accuracy and statistical integrity of tables, listings

and graphs provided by vendors.

PROFESSIONAL EXPERIENCE

President and Owner

Chris Barker Statistical Planning and Analysis San Carlos, Ca 2008 - Present

Services, Inc.

Statistical Consultant

Statistical consultant for Bay Area Pharmaceutical and Device companies. I prepare statistical sections of

protocols, statistical analysis plans, programming specifications, and verification for phase I, II and III

clinical studies, Integrated summary of Efficacy and Safety (ISE, ISS) case report forms and data entry

specifications. Currently I prepare statistical analysis plans for Phase I 3+3 study designs. I reviewed

and verified the statistical integrity of clinical study reports, including a Thorough QT study. My work has

included verification of pharmacokinetic calculations and development of procedures for verifying

analyses that use WINNONLIN. Prepared complex statistical analyses for a manuscript submitted to a

major cardiovascular journal. I collaborated with regulatory, clinical, QA, bio-analytical, programmers and

data managers in monitoring on-going clinical trials, including database locks and un-blinding.

Page 1 of 4 Chris Barker

Associate Director of Biostatistics

2005 2008

Johnson & Johnson Pharmaceutical (JnJ) Mountain View CA

Research and Development

(after reorganization of Alza and Scios)

Associate Director of Biostatistics

Prepared statistical analysis plans, sample size, and clinical study reports by ICH guidelines, for

Natrecor pK and Phase I, II and III clinical trials and JnJ Diligence team Licensing and Acquisition

Projects. Supervised the activities of several CRO s in preparation of case report forms, electronic

data capture (EDC), data quality checks, IVRS and Tables, listings and graphs. Verified statistical

integrity of all tables, listings and graphs and final clinical study report publication for several Natrecor

clinical trials. I was the Scios statistical expert for statistical analysis plans and implementation for

health economics and Patient Reported Outcomes (PRO s) analyses in any Scios study. Provided

pre-IND statistical materials, and drafted the Target Product Profile for a First in Human study of the

VEGF-121 molecule for pre-eclampsia. Led a cross-functional team of three programmers and an

economist and prepared novel statistical analyses of Health Economics outcomes for abstracts and

publications for both clinical trial data and a large (600K+ claims) insurance claims database. The

statistical analysis of claims data won a Best Poster Award in 2007 at ISPOR.

Genentech, Inc South San Francisco 2003 2005

Senior Statistical Scientist

Planned statistical analyses for a supplemental registration, and responded to FDA questions about

post Marketing requirements for HERCEPTIN, in adjuvant and first line treatment in HER2+ metastatic

breast cancer. Developed statistical analysis plans, including specifications for Group Sequential

Interim Monitoring Boundaries with an alpha spending function for a Genentech supported National

Cancer Institute Phase III trial involving ~ 6000 Women. Provided statistical evaluations of proposals

for Investigator Sponsored Trials. Prepared abstracts and publications for HERCEPTIN Phase IV

studies.

2001 2003

MEDTAP International, Inc. (Acquired by Redwood City, CA

United Biosource)

Director, Statistical Research

Provided statistical consulting and training for MEDTAP clients and MEDTAP Health Economics and

Outcomes Scientific staff in areas ranging from multiple comparisons, multivariate analyses, such as

canonical correlation, factor analysis, cluster analysis, and linear mixed effects models resulting in

posters abstracts and publications. Planned and prepared statistical analyses of work impact due to

schizophrenia using a large (300,000+ insured) Health Insurance Claims database as requested by a

client. One publication received a Public Health Service Award. Supervised and scheduled project

work of one statistician and one programmer.

Page 2 of 4 Chris Barker

ROCHE Pharmaceuticals 1995- 2001

Palo Alto CA

Pharma Business Strategy

Health Economics and Strategic Pricing

Principal Pharmacoeconomic Statistician

First statistician in this newly created position and sole statistician for the department. I supervised

the statistical programming of up to four Programmers. Provided training in statistical methods and

prepared statistical analyses for up to ten economists for all Roche Phase III clinical trials used in

economics models of Cost Effectiveness, Cost Offset and Cost Utility and various PRO and

Outcomes publications. The therapeutic areas for these projects included: Transplantation, AIDS

Retinitis CMV, Breast, Renal and Colon Cancers, Influenza, Hepatic Cirrhosis, Obesity, Rheumatoid

Arthritis, Osteoporosis, Congestive Heart Failure, Parkinson s disease, Cardiovascular and

Urological. The statistical work was included in economic models submitted for successful

reimbursement decisions by the National Institute for Clinical Excellence (NICE), also Canadian,

Australian and other reimbursement agencies.

ROCHE Pharmaceuticals (acquired Palo Alto CA 1994-1995

Syntex)

Principal Statistician

Project Statistician for the CELLCEPT in Renal Transplantation Dossier registration team, prepared

Syntex s single largest dossier for successful international submission and registration in North

America, Europe, Asia and Australia. I participated in all key FDA interactions, including End of Phase

II, response to FDA questions and responded to questions at the FDA Advisory hearing for

CELLCEPT. I prepared responses to regulatory questions arising from US (FDA), the European

Rapporteur, and Australian, Canadian and Japanese and other regulatory authorities.

Syntex Pharmaceuticals Palo Alto CA 1990-1994

Research Biostatistician II

(Project Statistician)

Determined sample sizes, and established project standards for statistical analysis methods, case

report form design, and data collection, data quality, for three planned pivotal Phase III clinical studies

of a novel immunosuppressant. Completed statistical analyses and final reports for an AIDS CMV

retinitis drug (Cytovene), an ophthalmic, Ketorolac, in accordance within project timelines.

Lorex Pharmaceuticals (a Joint Venture of Skokie, IL 1988-1990

Searle and Synthelabo Pharmaceuticals)

Senior Biostatistician

Prepared sample size, statistical analysis plans, and final clinical study report of a pivotal Phase III

clinical trial leading to a successful registration and labeling of a sleep hypnotic, AMBIEN. I prepared

statistical analyses of clinical trials included in the successful registration of Kerlone and the antibiotic

Maxaquin.

Page 3 of 4 Chris Barker

EDUCATION

Ph.D. Biostatistics. University of Illinois Health Sciences Center. Chicago, IL.

M.Sc. Biostatistics. University of Pittsburgh. Pittsburgh, PA.

M.A. Economics. Northwestern University. Evanston, IL.

B.A. Economics. University of Colorado. Boulder, CO.

TECHNICAL EXPERTISE

Statistical - linear mixed effects models, univariate and recurrent event survival analysis,

multivariate analyses including factor analysis and other psychometric methods.

Statistical Programming SPLUS, SAS, R, EAST, WINNONLIN and Nquery.

Operating Environments - UNIX and WINDOWS.

Journal Statistical Reviewer

Journal of Clinical Oncology: 2005 present.

Journal of Biopharmaceutical Statistics: 2007 present.

Value in Health: 2007 present.

Journal of Controlled Clinical Trials: 2009 present.

Page 4 of 4 Chris Barker

Contact this candidate