Sunny du
Director, Statistical Programming at Hengrui USA
- Role
- Director, Statistical Programming at Hengrui Usa
- Location
- Princeton, NJ, US
- LinkedIn followers
- 500 followers
About Sunny du
PROFILE: • 20+ years SAS programming experience in pharmaceutical industry, working in statistical programming and DM clinical programming divisions, with experience from Phase I to Phase IV clinical trials in Oncology, CV, GI, Respiratory, CNS, Infection, Sleeping Disorder and Osteoporosis therapeutic Areas.• Comprehensive knowledge of clinical trial data related activities from data collection (CRF design, database setup, data extraction, edit check programming) to data analysis (CDISC SDTM, ADaM, data, Specs and define file creation, table, figure, listing generation and statistical analysis).• FDA and EMA submission experience.• Highly organized, detail oriented and results focused.SKILLS: • Programming: SAS/Base, SAS/Stat, SAS/Graph, SAS/Macro, SAS/SQL, SAS/ODS, UNIX Shell Scripting, C Language.• Statistics and stat programming: experimental design, statistical analysis, SDTM, ADaM and TFLs creation.• Database: Oracle and RAVE databases.• Experience in oncology clinical trials and oncology data derivations.• CDISC: knowledge and hands-on programming skills for SDTM, ADaM, Data, Specs and Define files.• FDA submission: solid understanding of FDA, EMA, ICH regulatory guidelines, BIMO data and SDSP doc generation.• Guidance document writing.
Experience
Director, Statistical Programming
Jan 2022 — Present · Princeton, NJ, US
Hengrui USA is the US subsidiary of Jiangsu Hengrui Pharmaceuticals, Inc.
Education
Nankai University
B.S., Biology
University of Maryland
M.S., Biostatistics
Chinese Academy of Sciences
M.S., Biology
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