William Sun Email & Phone Number

Wilmington, Delaware, United States

Wilmington, De

1) Established and developed an effective biostatistics and programming group 2) Designed and established a company standard SAS working environment for the biostatistics department to conduct statistical analysis and reporting of all in-house clinical trials 3) Developed a standard SAS TLF macro system to achieve both efficiency and consistency 4) Established a statistical methodology library for training and sharing purpose, which includes common methods and key consideration for analyzing survival data, gate-keeping methods for family-wise error control, Bayesian methods for early phase studies, Poisson methods for safety monitoring, etc.Managing people including hiring, training, developing and resource allocation Managing projects including planning, budgeting, timelines, procedures, and delivering5) Conducting executive review of all company sponsored meeting presentations and publications 6) Participating in protocol development of critical studies and SPA negotiation with FDA 7) Developing and maintaining SOPs and guidelines 8) Developing and maintaining a SAS standard macro reporting system 9) Writing statistical analysis plans of critical studies 10) Carrying out critical efficacy and safety analyses Interpreting results and writing statistical summary reports 11) Conducting data mining and ad hoc analyses for new study designs and additional publications 12) Managed the biostatistics group with up to 5 direct reports until January, 2011 Managed the programming group with 12 direct/indirect reports during 2011-2012 13) Managing a group of 3 biostatistics and 3 programmers in global medical affairs since January, 2013