职位描述
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职位描述:
职责描述:
1. providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., cros) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, integrated summaries of safety (iss), integrated summaries of efficacy, dsur, psur, ib, progress reports, electronic submissions and other internal and external requests (e.g., publications).
2. accessing and converting data to sas from database management system and pc file formats (e.g., ms excel, text files).
3. develop or monitor the content and structure of sas data sets.
sdtm and adam technical knowledge required. in addition, knowledge of agency requirements including ich, fda, cfda and other guidances is strongly recommended.
4. good understanding with different phases of clinical trials, protocols, and crf designs. providing input in developing statistical analysis plans, producing specifications of analysis datasets, validation plans, and other related documents
5. working independently as well as in teams to accomplish tasks and goals defined by supervisor. attending required training and meetings and bringing in new ideas to improve the programming process.
任职要求:
1. 数学、统计学、医药统计学、计算机或者相关领域的专业本科、硕士。
bsc/ msc in mathematics, statistics, medical statistics, computer science or related field.
2. 在医疗环境或者相关统计应用领域作为统计编程(sas)人员的经验至少3年相关经验,
minimum 3 years' experience in sas programming in biostatistics department environment for phase i-iv clinical trials in a pharmaceutical/cro environment.
3. 熟练使用 sas编程语言包括sas-base, macro, stat, graph, access etc
strong skill in sas programming, using sas-base, macro, stat, graph, access, etc.
4. 熟悉cdisc, sdtm and adam 标准
knowledge of cdisc, sdtm and adam standards.
优先条件:
1. 对sas编程集成环境的创建,对sas macro的编写有丰富的经验。
experience with sas integrating environment establishment, strong skill in sas macro programming.
2. 熟悉注册数据的提交格式和过程
define.xml knowledge and familiarity with a submission process is preferred.