Sky Tian Chen

Background

About Sky Tian Chen

QUALIFICATIONS AND SUMMARY • Five years of CRO experience with supervising the data management and statistical analysis in the clinical trial field. Manage data management, statistical analysis, and programming activities company-wise and present CRO in all statistics aspects. Before working in CRO, I also had five years of post-doctor fellow experience with developing statistical methodology development and application in the area of biopharmaceutical/clinical statistics. • Over the past years, I had joined the clinical trials about the COVID-19 vaccine, Enterovirus 71 vaccine, influenza vaccine, rheumatoid arthritis biologics, non-alcoholic fatty liver disease, asthma, bowel preparation prior to colonoscopy, vaginal moisturizer in post-menopausal women, dry eye disease, risedronate sodium for postmenopausal osteoporosis, AI decision of fundus image, and post-marketing surveillance of Ampholipad in Taiwan. I was involved in phase I~IV studies, medical device studies, and also AI validation studies. WORK EXPERIENCE NHRI: Postdoctoral Fellow, 2012 ~ 2017 StatPlus, Inc: Associate Director, 2017 ~ 2020; Director, 2020 ~ present Job Responsibility: • Supervise all data management, statistical analysis and programming activities company-wise. Supervise CRF, electronic data capture database/Oracle clinical database, statistical analysis plan, statistical report, and clinical study report development. To be responsible for project planning in data management, statistical analysis, programming, and report. Review and approve the randomization plan and schedule generation, the data management plan (DMP), data validation plan (DVP), statistical analysis plan (SAP), and mock tables. Supervise the programming for data validation/cleaning, clinical study dataset and analysis dataset preparation to format-specified datasets (CDISC, SDTM, ADaM) for analysis TFLs. Interpret analysis results for clinical scientists in a statistical point of view. Respond to the questions raised by regulatory agencies and/or sponsor.