Tom has worked in drug development for 25 years as a statistician and statistical programmer, developing and evaluating clinical trial designs and writing and executing statistical analysis plans. Presently, he works with a global health funding organization to maximize the benefits of their philanthropic activities by helping teams to make data-driven investment decisions to maximize the informativeness of clinical trials through innovative and efficient trial designs.
In his current and previous roles Tom has provided statistical consulting, sample size calculations, study design/simulations and study analyses to pharmaceutical and biotechnology clients. He has collaborated 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.
Prior to joining Certara Tom served as the Data Science and IT lead for a consulting company that he founded with several former colleagues. In this role, Tom worked with external providers to solve technical problems, developed a file security model that met business needs and prioritized hardware/software investments. He was responsible for maintaining the company’s statistical programming environment in a qualified state, consistent with 21 CFR Part 11 requirements, including the validation of additions and changes to the environment. He developed 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.