- 行业:药品
开拓药业欢迎最新从事过生物工程/生物制药等行业的优秀人才加入我们,苏州开拓药业股份有限公司将为您提供广阔的发展平台!
职责描述:
? Assess CRO’s competences and capabilities in vendor selection
? Monitor and collaborate with CROs to ensure quality and on-time deliverables in
programming
? Provide programming plan (timeline, strategy to ensure the efficiency and the quality) for
a study
? Develop SAS programs and macros in support of programming activities
? Well know of CDISC standards (SDTM and ADaM)
? Well know and real experience in eCTD preparation for NDA submission
? Well know of RECIST v1.1, programming check the tumor responses in solid tumor
studies
? Skilled in SAS is mandatory, expertise in R, C++, Java, or Python, will be an advantage
? Good at SAS graphics (standard and non-standard figures)
? Leadership
任职要求:
Education: Bachelor or Master degree in statistics, medical statistics, clinical
epidemiology, computer science, mathematics, biology or other scientific field (or
equivalent theoretical/technical depth)
? ≥5 years programming experience with B.S. degree, ≥3 years with Master degree,
preferably in a pharmaceutical/CRO company
? Extensive knowledge of SAS programming language
? Good in written English and workable in oral English
? Team work, fast learner and details oriented
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