Thomas Peppard Email & Phone Number

Radnor, Pennsylvania, Us

• Model client data and simulate candidate clinical trial designs for Phase 1-3 studies. Advise clients on pros/cons of different designs.• Recommend/simulate different interim analysis decision rules using group sequential methodology. • Review draft protocols and simulation results to advise on design improvements, with special attention to non-inferiority trials and cluster randomized trials, which have historically had high rates of failure.• Devise a strategy to identify an optimized regimen of antenatal corticosteroids for the promotion of fetal lung maturation. Review literature and emerging data to determine effect sizes required for regimen advancement. Identify preclinical and clinical data sets used to model drug response and simulate candidate trial designs.• Serve as study statistician, writing statistical analysis plans, overseeing production and quality of datasets and tables/figures/listings, preparing top-line reports and reviewing clinical study reports.• Led a group of 5-to-7 programmers curating data for a secondary research project, with contributions from over 200 clinical trials, birth cohort studies and other observational studies of maternal, neonatal and children’s health.• Develop tools to facilitate analysis of child anthropometric data based on WHO growth standards

• Provide statistical consulting, sample size calculations, study design/simulations and study analyses to pharmaceutical and biotechnology clients.• Collaborate on the formulation of clinical development plans, including: review of literature to determine effect sizes required for approval and commercialization; review of health authority approval documents to devise strategies for endpoints; and evaluation of operating characteristics for interim analysis and program-level decision criteria.• Write statistical analysis plans and execute analyses for clients.• Maintain statistical programming environment in a qualified state, consistent with 21 CFR Part 11 requirements, including the validation of additions and changes to the environment.• Develop corporate SOPs for the QC of statistical analyses, the validation of system-level code, the maintenance of the computer network and the plan for business continuity/disaster recovery.• Serve as the company's internal IT lead, working with external providers to solve technical problems, develop a file security model that meets business needs and prioritize hardware/software investments.• Oversee outsourced data management activities.

Reykjavík, Capital Region, Is

• Provided statistical support for clinical programs, including protocol design, sample size calculations, writing statistical analysis plans and analyzing phase I-II clinical trial data.• Maintained clinical data reporting systems according to corporate SOPs and 21 CFR Part 11 requirements.• Managed resourcing of programming and data management functions to support clinical trial research.• Provided programming support for phase I-II clinical trials, including production of tables, listings, graphs and analysis datasets.

New York, New York, Us

• Managed a group of 4-10 SAS programmers with responsibility for phase II-III inflammatory disease and pulmonary disease projects, including preparations for 2 NDAs. Responsible for production of tables for SCS and electronic submission components.• Maintained a legacy SAS programming environment: answer user questions; modify code to support Oracle Clinical system updates and medical dictionary updates; manage server migrations; plan for system retirement.• Managed programming for a co-development project: jointly developed and met timelines; jointly established conventions for programming and data transfers; implemented security measures to protect intellectual property.• Implemented a sourcing strategy to receive programming support from preferred providers.

New York, New York, Us

• Managed a group of 4-6 SAS programmers with responsibility for phase II-III cardiovascular and pulmonary disease projects.• Supported eplerenone heart failure NDA from submission through labeling, including advisory committee preparations.• Validated and maintained a library of SAS macros that automated the creation of standard datasets for safety analyses.• Advised database standards group in order to insure that database implementation in Oracle Clinical would meet the technical requirements of the SAS programming environment.

New York, New York, Us

• Supported phase II-III clinical research in oncology and cardiovascular projects.• Developed statistical macros in SAS to analyze multiple endpoints in multi-cycle chemotherapy trials and to calculate Hodges-Lehmann point estimates appropriate for trials with small sample sizes.• Responsibilities included: writing statistical sections of protocols and statistical analysis plans; calculating statistical power and sample sizes; reviewing study reports; overseeing production of statistical tables and graphs; verifying statistical output; and reviewing study reports.

Abbott Park, Illinois, Us

• Supported phase II-III clinical research in the Pharmaceutical Products Division.• Worked on the NDA for ritonavir, an HIV protease inhibitor, which was approved within a year of the start of Phase III trials.• Supported the pediatric regulatory submission for ritonavir.• Responsibilities included: Programming tables and graphs in SAS; reviewing study reports; identifying data discrepancies.

Ms, Statistics

Bs, Mathematics & French