Biostatistics and and Applied Mathematics: Expert and Consultant

Technical Consultant #1229


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
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