J. Eileen Burns, Ph.D., M.A.

*** ***** **** *****

Blue Bell, PA 19422

215-***-****

abid9e@r.postjobfree.com

______________________________________________________________________

EXPERIENCE

Octagon Research Solutions 2008-2010

Director of Biostatistics / Principal Consultant

• As Biostatistics Director, provided oversight for all phases of statistical activities of the

biostatistics team; allocated and managed resources (lead and supporting statisticians) for

each project; addressed clients’ needs and concerns.

• Provided strategy and leadership for all statistical functions: developed and mentored

technical staff; developed project strategies, timelines and deadlines and worked with team

and other departments to expand their statistical knowledge and hands-on experience;

developed and implemented QC strategies to ensure timeliness and quality deliverables to

clients; consistently received accolades from sponsors for the high quality and timeliness of

deliverables.

• Created and trained productive and efficient Biostatistics Team, selected and interviewed

biostatistician candidates; performed quarterly performance reviews; made biostatistics team

an integral part of the company.

• Led team by example as Hands-On, Lead Statistician on several projects; wrote statistical

sections of protocols; reviewed protocols, providing comments.

• Provided guidance and oversight for statistical projects including developing and/or reviewing

the statistical analysis plans (SAPs), performing efficacy and safety analyses, designing and

reviewing protocols and CRFs, reviewing study summaries and data displays, coordinating

team activities, along with client and FDA interactions.

• Actively participated in Data Safety Monitoring Board (DSMB) activities as unblinded

statistician; brought broad DSMB experience to clients, writing DSMB charters and guiding

other DSMB activities; served as resident expert regarding DSMB regulations.

• Ensured adherence of departments and company SOPs to FDA regulations; revised SOPs

and Guidelines; developed new SOPs and Guidelines for new procedures.

• Created Phase I and Late Phase SAP templates for Starting Point™.

• Provided clients with expert guidance and recommendations regarding regulatory strategies;

counseled clients regarding FDA regulations and regulatory requirements; coordinated

biostatistical activities with staff and clients in preparation for regulatory submissions;

provided supportive statistical information for regulatory agencies.

• Worked seamlessly with all departments and clients, integrating well with all areas that

support the biostatistical arena within the company and with sponsors.

MDS Pharma Services (2003-2008)

Director of Biostatistics & Programming 2004-2008

• Coordinated globally with European counterparts; established global SOPs and Guidelines,

training plans and global costing models; worked to establish global harmonization of

European and North American Biostatistics and Data Management departments; worked to

improve global communication, common processes, hardware and software, and costing of

products.

J. Eileen Burns, Ph.D., M.A.

Page 2 of 7

• Allocated Biostatistics staff to portfolio needs; responsible for initiating resources to assist

with the resource peaks based on portfolio requirements.

• Is people-management focused which includes defining goals, development plans and

performance reviews on a quarterly basis; involved in all aspects of individual study logistics,

proactively problem-solving.

• Created and maintained positive and cooperative team environment, working with team

members collectively and individually to maintain cooperative team spirit: team members

worked hard to achieve their optimum productivity level and enjoyed doing it.

• Ensured that cost, quality and speed metrics were tracked accordingly and were in line with

business targets for the Biostatistics group; directed the activities of all projects completing

them by or before deadline, on or under budget and with highest quality.

• Directed statistical activities associated with clinical research studies, including writing,

reviewing and approving statistical sections of protocols, providing input to study design,

sample size calculations, detailed statistical analysis plans, data display validation, and

statistical reports prepared by statisticians prior to release to sponsor.

• Served as Lead Biostatistician on Data Safety Monitoring Boards (DSMBs) and was sought

after as the resident expert on DSMBs, providing guidance on setting up the committees,

writing the charters, etc.; represented Biostatistics Department in bid defenses,

presentations, and reports to clients.

• Addressed all statistics related issues and queries raised by regulatory agencies; has broad

experience with FDA regulations; served as statistical consultant to clients, providing

methodological input to regulatory submissions.

• August, 2006 – May, 2007: Group Leader for Data Management, successfully serving as

Interim Head of Data Management, the Americas, in addition to continuing responsibilities as

Director of Biostatistics; directed initiation and implementation of Electronic Data Capture

(EDC) for the Data Management team during that period.

• Member of the Leadership Group, an elite think tank for policy making for company.

• Organized and conducted interactive meetings all departments: Biostatisticians, SAS

Programmers, Data Management, Project Management, Quality Assurance, Medical Affairs,

Medical Writing, etc., coordinating study activities.

• Built the North American Biostatistics Group: Grew Biostatistics Department by 100%

(increased the team to twice its size), increased Biostatistics business by 500%, and

increased departmental efficiency by 250% (with 50% repeat business).

MDS Pharma Services (continued)

Senior Biostatistician/ Manager, Biostatistics & Programming 2003-2004

• Performed statistical analysis and review. Represented departments in studies and programs

for regulatory submission, statistical contact with sponsor.

• Conducted advanced statistical analyses in support of clinical research studies.

• Established departmental processes, interacted with other departments, trained staff, and

made hiring decision.

• Represented the department in project teams for clinical studies and/or programs leading to

regulatory submissions. Served as statistical contact with sponsors for

projects of diversified scope. Served as project leader for multi-study programs.

• Created bids for biostatistics for RFPs; represented Biostatistics department for Bid Defenses

with Clients; made final presentations to clients.

• Interacted with Project Management, Data Management, and/or Clinical Writing regarding

aspects of studies. Participated in DB and CRF design, and reporting of results.

J. Eileen Burns, Ph.D., M.A.

Page 3 of 7

• Interacted with the internal/sponsor’s biostatisticians regarding all statistical aspects of clinical

trials. Interfaced with IRG department personnel and with project team members. Supervised

biostatisticians, statistical SAS programmers and data analysts.

Wyeth Pharmaceuticals Research Global Safety Surveillance & Epidemiology 2001-2003

Associate Director, Biostatistics & Programming

• Provided integral statistical consultation for study design, data analysis and data

interpretation.

• Directed statistical components for epidemiological research and safety surveillance studies.

• Performed statistical analyses on results of clinical trials for Phase IV and post-marketing

studies for drugs and vaccines.

• Researched, evaluated and implemented new trends in statistical methodology such as

Proportional Reporting Ratio, Self-Controlled Case Series Design, Data Mining, Case Cross-

Over Design, particularly in analysis of safety surveillance and adverse event data; created

and delivered presentations to the epidemiology group and safety surveillance teams

regarding these new techniques.

• Developed statistical sections for safety surveillance and epidemiology groups dealing with

results of analyses for periodic reports to various regulatory agencies.

University of Pennsylvania School of Medicine

Center for Clinical Epidemiology and Biostatistics 1990-2001

Senior Research Project Manager

• Directed multiple NIH-funded studies simultaneously; studies dealt with renal epidemiological

and health outcomes research as survival/risk factors involved with various methods of

hemodialysis, grafts, kidney transplants, stroke, etc. Performed statistical analysis on data

and reported results for publication and presentation.

• Recruited, supervised and trained medical personnel as research assistants for the collection

of data via patient interviews and extraction from medical records.

• Consulted with multicultural, multidepartmental professionals providing them with seamless

direction in the collection, entry and organization of data; performed analyses

for their diverse research projects dealing with Breast Cancer, Prostate Cancer, End Stage

Renal Disease, Diabetes, Lipids and Cardiac disease, Lead Poisoning, etc.

• Directed complex longitudinal study, collecting and analyzing data using the electronic

monitor cap to measure compliance in kidney recipients by tracking use of

immunosuppressive pharmaceuticals (Cellcept, Imuran, Prednisone, Prograf).

• Developed and refined an observational instrument for measuring depression in stroke

survivors; performed construct, content, face, and criterion validity, as well as inter-rater

reliability and within-subject reliability for the instrument; performed exploratory and

confirmatory factor analyses.

• Was grant statistician, solely responsible for performing statistical analyses on data in

preparation of reports, publications and presentations.

• Increased subject accrual by 390% annually over a three-year period without increasing

support staff, by instituting more efficient management techniques. Directed multi-stage

evaluations of patients according to protocol.

J. Eileen Burns, Ph.D., M.A.

Page 4 of 7

Philadelphia Geriatric Center 1988-1990

Director of Data Operations

• Directed all phases of data collection and analysis.

• Created and maintained several extensive databases for NIMH grants studying Alzheimer’s

Disease, caregiver burden and institutionalization of the elderly.

• Managed and directed personnel in data entry and data cleaning.

• Performed statistical analysis and also assisted in researching, creating and writing winning

grant proposals and various journal articles.

Medical College of Pennsylvania 1985-1988

Chief Research Assistant

• Responsible for conducting pharmaceutical randomized clinical trials for NIMH-funded grant

comparing antidepressant drug therapy with placebo groups and two kinds of psychotherapy

in 2X2 Mixed Factorial Design.

• Analyzed data, publicized study, recruited and screened candidates for study.

Medical College of Pennsylvania 1984-1985

Research Assistant

• Involved in research of the use of behavioral techniques (systematic desensitization) with

depressed and anxious patients.

• Developed therapeutic skills for treating anxiety disorders using behavioral techniques.

• Collected and entered data, performed statistical analysis, reported results in subsequent publication.

QUALIFICATIONS

B.S. Psychology, 1982 - Frostburg State University (Summa Cum Laude)

M.A. Experimental Psychology, 1985 - Bryn Mawr College

Ph.D. PREM/Statistics, 1998 - University of Pennsylvania

PROFESSIONAL

American Statistical Association

Society for Clinical Trials

Drug Information Association

THERAPEUTIC and BIOSTATISTICS EXPERIENCE

Therapeutic areas: Diabetes, Renal Disease, Hemodialysis procedures, Kidney Transplant, Cardiovascular, Stroke,

Depression, Anxiety, Breast Cancer, Prostate Cancer, Women’s Health, Compliance, Genomics, Psychometrics, Quality of

Life, Alzheimer’s Disease, Cushings Disease, Opioid Delivery Systems, AML, Vaccines, GVHD, Celiac Disease, Small

Cell Lung Cancer, Metabolic Disorder, Asthma, Leukemia, ADHD, Diabetic Wound Healing, VOD, Smoking Exposure,

Therapeutic Devices, Pain Management Systems, and others.

Software Expertise: SAS (completed all courses for Certification at SAS Institute in 2003); nQuery Advisor;

Comprehensive Meta-Analysis (CMA); SPSS; STATA; EAST; MicroSoft Office, etc.

J. Eileen Burns, Ph.D., M.A.

Page 5 of 7

MAJOR PRESENTATIONS

American Congress of Rehabilitation Medicine, Annual Meeting, Minneapolis, MN.:

“Depression in Stroke Survivors: Gender Issues”.

JANS International Nursing Research Conference, Tokyo Japan: “The Comprehensive Mood

Index: An Observational Tool to Measure Depression”.

Eastern Psychological Association Convention, Boston, MA.: “Susceptibility to Masking of Emotional Expressions”.

MINOR PRESENTATIONS

At Wyeth, delivered presentations on many topics internally. These include:

• Proportional Reporting Ratio

• Self-Controlled Case Series Design

• Data Mining

• Case Cross-Over Design

• Using the Incidence/Prevalence Database

At MDS, delivered approximately 85 Bid Defenses to various sponsors on many different studies,

therapeutic areas, employing many different biostatistical techniques and designs.

Gave many different internal presentations, including:

• Phase IV methodologies

• Global costing models

• Group Sequential Modeling

• SOPs and Guidelines

• Etc.

PUBLICATIONS

Feldman, H. I., Rosas, S.E., Burns, J. E., Knauss, J., Brayman, K. Predictors of successful

arteriovenous fistula maturation. American Journal of Kidney Diseases, 42(5). 1000-

1012, 2003.

Feldman, H. I., Burns, J. E., Roth, D. A., Berlin, J. A., Szczech, L., Gayner, R., Kushner, S.,

Brayman, K. L., & Grossman, R. A. Race and Delayed Kidney Allograft Function.

Nephrology Dialysis Transplantation, 13, 704-710, 1998.

Feldman, H. I., Gayner, R., Berlin, J. A., Roth, R., Silibovsky, R., Kushner, S., Brayman, K. L.,

Burns, J. E., Kobrin, S. M., Friedman, A. L., & Grossman, R. A. Delayed function reduces

renal allograft survival independent of acute rejection. Nephrology Dialysis

Transplantation, 11, 1306-1313, 1996.

Feldman, H. I., Fazio, I., Roth, D., Berlin, J. A., Brayman, K., Burns, J. E., & Grossman, R. A.

Recipient Body Size and Cadaveric Renal Allograft Survival. Journal of the American

Society of Nephrology, 7(1), 1996.

J. Eileen Burns, Ph.D., M.A.

Page 6 of 7

Whitney, F., Michaels Burns, E., Frederick, M., & Lowery, B. Recognizing Depression

Following Stroke: Preliminary Results. Rehabilitation Nursing Research, Winter

Issue, 3(4), 1994.

Whitney, F. W. & Burns, E. Recognizing Depression: Preliminary Testing of the Whitney

Observational Depression Index. Journal of Stroke and Cerebrovascular Disease, 3(3),

193-201, 1993.

Pruchno, R. A., Michaels (Burns), J. E., and Potashnik, S. Predictors of institutionalization

among Alzheimer’s Disease victims with caregiving spouses. Journal of Gerontology,

Social Sciences, 45(6), 259-266, 1990.

Pruchno, R. A., Kleban, M. H., Michaels (Burns), J. E., & Dempsy, N. P. Mental and physical

health of caregiving spouses: development of a causal model. Journal of Gerontology,

Psychological Sciences, 45(5), 192-199, 1990.

Wolpe, J. and Michaels (Burns), E. The subcategorization of nonpsychotic depression in

behavioral and nonbehavioral research. Journal of Behavioral Therapy and

Experimental Psychiatry, 17, 91-93, 1986.

ADDENDUM

STATISTICAL CONSULTING EXPERIENCE

2000-2002 Yale University & University of Pennsylvania

School of Nursing School of Nursing

New Haven, CT 06536 Philadelphia, PA 19104

American Cancer Society Study of Nursings’ Impact on Quality of Life Post-Prostatectomy

• Performed statistical analyses using many large longitudinal data sets studying the effects

nursing interventions on males recovering from Prostate Cancer surgery and their caregivers.

• Supervised and directed maintenance and cleaning of many large longitudinal databases.

• Reported and interpreted results of analyses for presentations and publications.

1994-1995 University of Pennsylvania

School of Nursing

Philadelphia, PA 19104

Nursing Intervention Lexicon and Taxonomy (NILT) Project

• Assisted in developing/ refining a classification system for nurses' interventions using categories

developed by Dr. Susan Grobe, Texas A & M.

• Extracted interventions from nurses' notes of interventions used during home-care of

prostate/breast cancer patients.

J. Eileen Burns, Ph.D., M.A.

Page 7 of 7

• Developed reliability tables to aid in training of coders; helped develop coding system.

• Supervised coding sessions to ensure reliability of independent nurse coders.

• Performed statistical analysis, Cohen's kappa, to determine inter-rater reliability in coding

interventions.

• Wrote the statistics and methodology sections for grant proposal to further test these categories;

this grant was subsequently awarded funding.

1994 The Partnership Group

Lansdale, PA

Employee Benefits Study for Banking Industry

• Assisted team in questionnaire development, measuring quality of life of employees.

• Supervised data collection and data entry of large quantity of questionnaires.

• Performed statistical analyses on these data.

• Developed a 110-page manuscript which dealt with all aspects of the client’s questions, providing

clear answers, supported by statistical analyses of the data. From this was constructed an

Executive Summary which was presented to the client.

1992-1993 Magee Rehabilitation Hospital

Philadelphia, PA 19102

Falls Study

• Created databases for data regarding the occurrence of falls by patients during their stay in

rehabilitation hospital; supervised data entry, coding, and cleaning.

• Developed a model for statistically predicting the occurrence of falls by use of the Logistic

Regression Model.

• Generated a table for use by rehabilitation nurses so that a fall could be predicted with 96.9%

accuracy (perhaps preventing a fall) given the occurrence of only 5 variables.

• Prepared presentation materials for presenting findings at various professional association

meetings.

Contact this candidate