职位描述
Responsibilities· Participate on Medical/Clinical/Regulatory teams supporting clinical studies and projects primarily in the Asian/Pacific region, and work as part of global teams to support global clinical studies and projects.· Support Data Management in data transfer, data creation, data integrity checks, and data audit. · Support Statistics in table, listing, and graph generation, and statistical analyses. · Develop general SAS macros for use by data managers or statisticians.· Responsible for assisting in recruitment of future colleagues as needed.· Proficient in SAS Base, STAT, Graph and Macro. Extensive experience using Data _Null_ and Proc Report. Knowledge of SAS SQL or AF/SCL, or Visual Basic is a plus. · Participate in setting up a study including the development of statistical methodology, fill up the statistical section of study protocol, perform sample size estimation, and carry out randomization procedure· Develop SAS programs to create statistical tables, listings, and graphics according to the statistical analysis plan· Perform quality control and/or second program validation of other programmers’ programs.· Participate in CRF design, review , database setup, data validation and ensure that all critical contents are included· Develop statistical analysis plan, data validation plan, data management plan and blind data review· All other duties as assigned Qualifications:· Graduate degree in public health, Biostatistics or related disciplines· At least 6 year experience of statistical analysis in a pharmaceutical or CRO setting· Excellent communication and interpersonal skills· Knowledge of ICH GCP and China GCP· Rich experience of SAS programming, 4+ years experience of SAS programming would be preferred· Being fluent in spoken and written English with CET-6.· Willingness and capability to take initiative and support other clinical research units to resolve variety of statistical related issues · Mentor or train entry level staff for SAS programming & statistics analysis methodProvide Statistical training for other departments inside organization and coordinate all the effort with other departments to support organization overall goal
