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.
• 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.

• 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.
• 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.

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.
• 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.

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