Elizabeth Ludington has approximately 20 years of experience in the pharmaceutical and biotech industries, working for both CROs and sponsor companies.  She has provided statistical, technical, and strategic expertise for pre-clinical studies, INDs, Phase 1-Phase 4 clinical studies, eCTDs, and post-marketing requirements. She has a special interest in the design and analysis of natural history studies in drug development, particularly for orphan diseases. Her statistical experience includes study design, protocol review, writing and reviewing analysis plans and statistical reports, and representing clients at meetings with regulatory authorities. She serves as a senior statistical consultant for programs at all phases of development, including participating in overall clinical development strategy and cross-functional regulatory and strategic alignment meetings. Prior to Agility Clinical, Elizabeth held positions as Vice President, Biostatistics at Synteract, Executive Director of Technical Operations and Biostatistics at Somaxon Pharmaceuticals, and statistical positions at Elan Pharmaceuticals and Statistics Collaborative. Elizabeth holds a PhD in Biostatistics from the University of Iowa and a MA in Mathematics/Statistics from Boston University.

clinical research