Biostatistics and and Applied Mathematics: Expert and Consultant

Expertise

• Clinical trials protocols, statistical analysis plan and clinical study reports.
• Bayesian inferential and decision analysis.
• Integrated Analyses of Efficacy and Safety.
• Due diligence.
• Pharmaceutical adaptive designs: blinded and un-blinded sample size adjustment, group sequential designs.
• Clinical trials sample size determination.
• Mixed models repeated measures models.
• Pharmaceutical product exposure modeling.
• Statistical programming in SAS (MACROs, IML, SQL, STAT, GRAPH, ACCESS).

Experience

Undisclosed Company, Associate Director, 2006 - Present

• Provide statistical advice, scientific leadership and oversight of statistical aspects of clinical studies.
• Senior review of deliverables [tables, figures and listings (TFL); statistical analysis plan (SAP); study protocols; case report form (CRF); study report].
• Development of statistical programming specifications in SAS.
• Mentoring of junior statisticians and client staff in personal and career development and in technical areas.
• Delivery of educational seminars. Comparisons of analytic methods.
• Sample size determination using meta-analysis.
• Clinical indications: oncology, diabetes, organ transplantation.
• Primary clinical indications: oncology, diabetes, organ transplantation.

Bristol Myers Squibb Co., Sr. Research Biostatistician, 2005 - 2006

• Protocol statistician for two Phase 3 diabetes clinical trials in a metabolic clinical indication.
• Responsible for standardization across six Phase 3 trials: study objectives; statistical analyses/conventions; CRF modules; tables, figures and listings (TFL).
• Simulation of multiple comparison methods.
• Mixed models repeated measures handling of incomplete longitudinal data. Investigative drug exposure modeling and estimation, for periodic safety update reports.

UCB Pharma, Inc., Biostatistician/Sr. Biostatistician, 2000 - 2004

• Statistical leadership for nine Phase 2 and 3 clinical trials, and integrated analysis of efficacy, in clinical indications of epilepsy, mania, bipolar disorder, depression, migraine headaches, neuropathic pain, post-herpetic neuralgia and social anxiety.
• Writing study protocols, SAPs, blinded data review plans and study reports; SAS programming; planning/performing randomizations; editing data management plans and data cleaning plans; design of TFL; decision (cost/benefit) analysis for clinical development planning combining marketing/sales data with clinical development costs; liaison with contract research organizations and management of activities; interacting with clinical staff to enhance statistical inferential reasoning; analysis programming resource planning.

Pharmaceutical Research Associates, Inc., Biostatistician II, 1999 - 2000

• Design and execution of Phase 2 and 3 clinical trials statistical analyses.
• SAPs (ICH guidelines); direction of analysis programmers in construction of SAS analysis datasets; mentoring and supervision of junior statisticians; sample size requirements calculations; validation of statistical techniques; design of TFL; SAS programming to produce TFL; advising clients on optimal analysis methods; model building; imputation of missing values; preparing data edit specifications and clinical study reports.
• Logistic regression, Kaplan Meier estimation, log rank tests, exact tests, Wilcoxon Rank Sum tests, ANOVA/ANCOVA, proportional hazards regression and categorical analysis.

Kansas Foundation for Medical Care, Inc., Biostatistician, 1998 - 1999

• Systematic analysis of Medicare and Medicaid claims, and other sources of health data, to assess intervention effectiveness, identify and analyze patterns and relationships, identify and design future quality improvement projects.
• Statistical leadership of epidemiological studies, quality improvement projects and surveillance activities.
• Critique and validation of health studies performed for the State of Kansas by managed care organizations and universities.
• Design of data collection tools. Generation of randomization schedules. Preparation of executive summaries and technical reports for internal and external customers.
• Management of seven junior statisticians and relational database analysts, providing statistical expertise, training and leadership.
• Auditing and improving analysis and SAS programming code produced by entire organization.

Independent Contractor, Statistician, 1994 - 1997

• Planned, performed and reported on a wide variety of analyses provided for the following customers:
• Old Dominion University
• Old Dominion Research Foundation
• Virginia Beach Public Schools
• Tabet Manufacturing Company
• U.S. Air Force
• U.S. Navy

U.S. Navy, Supply Corps Officer, 1986 - 1992

• Supervision of up to 110 staff providing payroll services, food service, and repair parts storage/issuance.

Honors & Publications

Achievements

• Combined sales and cost data with measures of uncertainty, to guide clinical development planning.
• Developed powerful SAS macros to produce a large number of standardized reports.
• Interacted with clients to reduce redundant analyses, properly adjust for multiple comparisons, migrate from usage of pvalues to confidence intervals and measures of evidence.
• Developed innovative and informative statistical analyses, to directly answer important scientific questions. In an intensely production-oriented work environment, orchestrated the transition of eight health data analysts and computer programmers from SPSS/Foxpro to SAS.
• Established company-wide policy for hypothesis testing, statistical modeling, data cleaning and project computer directory structures.
• Constructed statistical protocol and performed analysis for epidemiologic monitoring and quality improvement projects, to estimate and test for improvements in clinical processes and outcomes.
• Introduced and applied important methods which corrected for secular trends and differences in distributions of prognostic factors. Drastically strengthened scientific rigor of study designs.
• Using general linear models, showed how modifying ships' restocking procedures would improve post-refitting efficiency. The Navy followed recommendations and has been successfully filling material requisitions in significantly less time for ships after refitting.
• Identified important trends in reasons corporate foundations give to higher education.
• Pinpointed, using survival analysis techniques, the extent to which expediting efforts were quickening material delivery to deployed Navy ships.
• Demonstrated statistically to the Virginia Department of Environmental Quality the satisfactory excavation and cleansing of a toxic waste site.

Publications

• 3 Publications

Languages

• Moderate proficiency in writing and conversation in Spanish.

Education

• Ph.D. Applied Statistics and Mathematics, Old Dominion University, Norfolk, VA
• M.S. Applied Statistics and Mathematics, Old Dominion University, Norfolk, VA
• B.S. Mathematics, Allegheny College, Meadville, Pennsylvania