Career Summary PhD statistical leader offering 17 years of drug development experience across all phases of drug development (especially Phases II-IV) in the pharmaceutical industry and CROs. Many additional years of experience working in health care research as a biostatistician and psychometrician. Global experience managing people (over 10 years) and projects across a broad range of therapeutic areas, including: Oncology, Cardiovascular, Diabetes, Endocrine/Metabolic, Women's Reproductive Health, Gastrointestinal, Infectious Diseases and Vaccines, Mental Disorders, Musculoskeletal including Arthritis, Neurology, Ophthalmology, Urology, Skin and Soft Tissue, and Pain Management. Submission experience and experience interacting with health authorities. Member of global leadership teams. Develop global, harmonized SOPs and specific quality processes and procedures for Statistics. Proven record of innovation and problem-solving and excellent knowledge of a variety of study designs and statistical methodology, including adaptive designs. Excellent consulting skills and collaborative approach. Areas of Special Emphasis Special emphasis (over 20 years' experience) on rare diseases involving registries, registry development and extraction of information from registries for patient selection and analyses. Experience fast-tracking projects for rare diseases through regulatory agencies. Special emphasis on oncology projects in lymphoma, Acute Myeloid Leukemia, breast cancer, lung cancer, prostate cancer, liver cancer. Special involvement in neurological diseases, many of which are orphan diseases and require adaptive design techniques and appropriate use of registry information and/or establishing registries. Involvement is most often as an unblinded statistician and includes protocol development, simulation studies, determining whether adaptive trial design techniques would be appropriate, sample size determination, development of complex randomization schemes, oversight of preparation of tables, figures and listings for interim analyses, DMCs and or DSMBs. Expertise in selection of appropriate efficacy endpoints.
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