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Position: Senior SAS Programmer
Position Description:
The Senior SAS Programmer performs all SAS programming tasks for a given clinical study or studies involving drugs, biologics and devices, acts as the primary point of contact for SAS programming activities for a given clinical study or studies and ensures adherence to guidelines, methodology and SOPs for software development in accordance with FDA, ICH, GCP and SDLC methodology.
Responsibilities Include:
·Builds standard tabulation datasets according to certain industry standard or the format requested by client or develops SAS programs to produce data listings and Case Report Form Tabulations as by domain or by subject displays
·Builds analysis datasets according to certain industry standard or the format requested by client based on the statistical analysis plan
·Develops SAS programs to implement statistical analyses as specified in the statistical analysis plans and table shells
·Develops SAS programs for other departments’ need such as Clinical Data Management, Medical Writing, Quality Assurance and Safety Department
·Performs validation of and quality assurance aspects of all SAS programming activities
·Represents SAS Programming at project team meetings and provides updates to project team on status of tasks
·Communicates with Project Biostatistician, Data Manager, Medical Writer, Project Manager and Project Coordinator regarding project issues
·Ensures adherence to all timelines associated with SAS programming
·Ensures integrity of all systems by preserving security and following change control procedures
·Ensures adherence to guidelines, methodology and SOPs for software development in accordance with FDA, ICH, GCP and SDLC methodology
·Other relevant duties assigned for which the incumbent is qualified.
Requirements:
·Bachelor’s degree in Biostatistics or statistics, medical or healthcare related education preferred.
·Minimum 2 years SAS programming experience in clinical research line.
·Good skills in the management and resolution of SAS programming issues.
·Demonstrated team-building skills and ability to work successfully in a team environment.
·Knowledgeable in all aspects of the Federal (FDA) regulations and requirements governing the conduct of drug, biologic and device studies including, but not limited to, GCP and ICH requirements
·Good command of English language and communication skills.
盖博医药信息咨询服务（上海）有限公司
Global Medical Consulting Services (Shanghai) Co., Ltd. (GMCS) is a wholly owned subsidiary of US-based Global Research Services, LLC (GRS). GRS has offices also in Canada, Germany, Poland, Britain, Brazil and India. GMCS is a leader in the management of clinical research programs for the pharmaceutical, biotech, and medical device communities. The company provides a full range of consulting and clinical trial management services that include protocol design, project management, data management, clinical site monitoring, biostatistical analysis, and medical report writing.
盖博医药信息咨询服务（上海）有限公司是一家国际性临床研究公司（CRO），总公司盖博研究服务有限公司（GRS）位于美国马里兰州罗克维尔市，并在加拿大、德国、波兰、 英国、巴西、印度以及中国设有分公司。作为GRS在中国注册全资子公司，盖博医药坐落于上海南京东路步行街黄浦商业圈。自1998年运营以来（前身为美国美迪范国际公司），盖博医药一直为全球的药厂、生物科技企业和医疗器械研发公司提供世界一流的临床试验及管理服务，包括临床管理、药物安全性管理、数据管理及生物统计支持等。
我们在世界各地与经验丰富的临床研究者及研究基地建立了广泛的联系网络，使得盖博能够为客户提供多种临床研究方案。
我们始终坚持高品质服务，在中国的本土团队也同样遵循ICH、GCP、FDA的工作标准，严格执行总公司的操作流程及客户所要求的操作规范。通过盖博在世界各地的分支机构的密切合作，有效保证了公司全球信息网络、信息基础架构、应用程序、通讯线路和备份系统符合FDA 21CFR11的要求。盖博医药曾多次接受并通过了诸多国际大药厂的审核，并有幸成为第一批通过中国国家食品药品监督管理局核查并获得高品质赞誉的临床研究合同委托公司（CRO）。
多年的积累，多年的奋斗，成就了今日盖博的辉煌和底蕴。总公司正在进一步加大在中国的投资和致力于中国团队的建设，盖博医药的目标是要成为员工和客户的最佳选择。
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电话：+86（21）3366-5188～90
应聘Email：shanghaihr@grs-cro.com
地址：上海市黄浦区南京东路299号宏伊国际广场1201室，200001
总公司网址： www.grs-cro.com
上海分公司网址：www.grs-cro.com.cn
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