Date: Thursday, January 27, 2022
Time: 1 pm Eastern Time
Costs: Free. Click here to register for Zoom link (please include a question that you wanted answered during the Q&A)
Description: Statisticians play a vital role in ensuring that safe, effective medicines get quickly to patients in need. You are invited to a webinar sponsored by the ASA's Section on Statistical Consulting to learn more about career opportunities for statisticians in drug development. Three experienced statisticians will discuss roles at a pharmaceutical company, a Contract Research Organization (CRO), and as an FDA reviewer. After their talks there will be an opportunity for a Question and Answer session. Students at all levels are especially encouraged to attend.
Jingjing Ye is the global head of Data Science and Operational Excellence (DSOE) with Global Statistics and Data Sciences (GSDS) in BeiGene. She has over 16 years of experience in the pharmaceutical industry and US FDA, with focus in cancer drug discovery and development. Her statistical and regulatory experience expands full spectrum on patients' treatment journey from diagnosis, treatment to living with the condition. She received her PhD degree in statistics from University of California, Davis.
Aparna Anderson recently joined Gates Medical Research Institute. She previously worked as Chief Scientific Officer at WCG Statistics Collaborative, Inc. and as Group Director at Bristol-Myers Squibb Company (BMS). As a clinical trialist for 24 years, Aparna has brought statistical and scientific perspectives to trial design, interpretation of trial results, and pipeline strategy, including proof-of-concept transition product development, due diligence for in-licensing and acquisitions, and go/no-go decision-making. In support of late-stage development and filings, she has interacted with regulators for end-of-Phase 2 and development discussions, pre- and post-submission meetings, and advisory committee presentations across numerous therapeutic areas, including rare diseases, neuroscience, pediatric indications, autoimmune diseases, metabolic diseases, infectious diseases, and cardiovascular diseases. She has also served on multiple data monitoring committees to provide patient safety monitoring and interpretation of interim efficacy analyses in clinical studies. While at BMS, she provided statistical leadership for the clinical development of ipilimumab and nivolumab, two pioneering therapies in the field of immuno-oncology. Before she worked in industry, Aparna was Assistant Professor in the Division of Biostatistics at the University of Minnesota. Aparna received a B.S. in Applied Mathematics from the University of California, Davis and her M.S. and Ph.D. in Biostatistics from the University of Washington. She spent a year studying mathematics as a Fulbright scholar at the University of Göttingen, Federal Republic of Germany.
Sirisha Mushti is a Biostatistician in office of Biostatistics at CDER, FDA, supporting the Division of Oncology 3 (DO3) that regulates the oncology product approvals for Gastrointestinal malignancies, melanoma and other advanced skin cancers, and sarcomas. Since joining FDA in 2013, Dr. Mushti has provided statistical support to the oncology solid tumors teams in reviewing oncology drug related applications submitted to FDA and has collaborated extensively with medical researchers on addressing statistical issues encountered in clinical trial designs. Her research interests include designs of oncology clinical trials in general and specifically that involves immunotherapeutic agents, group sequential designs, and addressing multiplicity issues involved in clinical trial designs. Dr. Mushti received her Ph. D in statistics from Old Dominion University in Norfolk, Virginia in 2013 and Masters in Statistics from Central University of Hyderabad, India in 2006. After completing Masters, she worked as a statistician in GSK Pharmaceuticals, India.