Paul Flyer, Ph.D. – Paul has over 25 years experience in the application of statistical methods. This experience has been obtained while in senior positions at the FDA, in the pharmaceutical industry (Amgen, Biogen Idec and ICOS) and as part of a major contract research organization (Westat). Paul’s primary areas of expertise are 1) developing statistical strategies for product registration, 2) optimizing the use of complicated study findings and 3) developing efficient implementation plans and processes for data collection, processing and analysis (validation and CDISC)
Brett Sellars– Brett has over 15 years of experience in clinical/statistical programming through positions in the bioscience industry (Amgen, Biogen Idec, ICOS, and Chiron Vision) and at consulting and CRO firms (Trilogy Consulting and PPD). He has experience managing and leading programming efforts on various Phase I through III studies and several NDAs and BLAs. Brett’s primary areas of expertise are in programming process development and standards and in CDISC data standards implementation.
Molly Fischer, CRNP, MPH – Molly brings over 20 years of experience in epidemiological and clinical research. This was through positions at academic institutions (University of Washington and George Washington University Biostatistics Center), the FDA, in the pharmaceutical industry (Amgen, and Biogen Idec) and as part of a major contract research organization (Westat). Molly’s principal areas of interest are clinical team management, study design, development plans, and literature reviews.
Joe Hirman, Ph.D. – Joe's experience includes leading statistical and programming teams for both large and small companies. While at GlaxoSmithKline he was responsible for statistical aspects of NDA and EMEA submissions and the corresponding regulatory meetings. He has additional experience with End of Phase II regulatory meetings in both the U.S. and Europe as well as CDRH advice meetings. Joe excels at bringing complex statistical concepts into a clear focus and ensuring the statistical and programming aspects of studies are completed on time and on budget. He has also played a lead role in the implementation of CDISC standards for PNWStat clients.
John Lubina, Ph.D. – John brings over 20 years of experience in devices, biologics, and drugs to PNW Statistics (including Amgen and Searle). With successful submissions and interactions with CDRH, CBER, and CDER as well as international experience in Europe and Japan, John’s principal areas of interest are in development plans, DSMCs, ad hoc and exploratory analyses, and support of regulatory submissions.
Edmund Ng, Ph.D. - Edmund is an independent statistical consultant with over 8 years of experience in the design and analysis of clinical trials and regulatory submissions. In the first 6 years of his career, Edmund was a Senior Statistician responsible for a rheumatoid arthritis clinical program at Amgen and Associate Director responsible for various oncology clinical programs at Cell Therapeutics. Since forming his own consulting business, Edmund has provided a wide range of statistical services for various pharmaceutical and biotech companies in the area of oncology, hematology, autoimmune diseases and medical devices. Edmund's primary areas of expertise are clinical trial design, statistical research and analysis, and programming validation.
Subo Yang - Subo is a statistical programming consultant with 10 years of experience in clinical research settings (Pfizer, Roche, Abgenix, Scios and Cell Therapeutics). Through working on phase I-IV clinical studies in various therapeutic areas, she has developed strong SAS programming skills and knowledge on statistical programming process, CDISC standards, and electronic submissions. Since leaving Cell Therapeutics as Manager of Statistical Programming in 2005, Subo has been a consultant to several pharmaceutical and biotechnology firms. Projects have included analysis files/tables/listings/graphs creation, system validation, utility macro development, and integrated safety database creation for BLA/NDA.