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MW(SM/AD)、CMO;临床药理经理;PVphysician

面议

上海市

刷新时间:2023-03-13

职位描述

SAS  manager-AD

工作职责

 Serve as the lead programmer on studies, work with clinical data management staff and biostatisticians to coordinate and schedule data transfers and the delivery of required outputs. 
 Plan and track the statistical programming activities including designing, developing, validating, updating, and documenting SAS programs to generate analysis datasets, data listings, summary tables, and statistical graphs supporting safety and efficacy analyses 
 Program for SDTM data mapping and creation of ADaM datasets and the corresponding specifications according to CDISC standards • 
 Program TLFs for implementation of the statistical analysis plans and for AdHoc analysis in clinical trial of all phases • 
 Perform programming QC on datasets and TLFs 
 Responsible for the creation and accuracy of regulatory submission data and clinical submission package 
 Work collaboratively with other functions to ensure clarity, accuracy and consistency of case report forms (CRFs) 
 Develop and comply with project/study programming standards and specifications according to regulatory guidelines and drug development principles 
 Maintain records for all assigned projects and archiving of trial/project analysis and associated documentation • • 
 Plan, develop, test, and document SAS macros for programming efficiency • 
 Oversee the development of datasets in SDTM format by CROs, including clear documentation of the process that was followed in the form of specifications, trackers, and checklists. 
 Responsible for programming QC oversight of CRO deliverables such as analysis datasets and tables, listings, and figures (TLFs). 
 Work on multiple tasks at the same time and prioritize tasks to meet business needs. 
 Trouble-shoot technical and project issues. 
 Communicate with outside departments and/or groups. 
 Meet timelines on a regular basis 
 Train/Onboard junior level programmers

工作要求

• Minimum of 3-4 years progressive Pharmaceutical/Biotech programming experience including macro/tools development experience 
• >1 year programming study lead experience 
• Excellent SAS Software Programming skills, including Base SAS, SAS/STAT, SAS/GRAPH and macro development 
• Ability to define and implement CDISC compliant SDTM and ADaM data and specifications • 
• Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions 
• FDA submission experience is highly desirable 
• Ability to thrive in a fast-paced environment managing multiple projects

其他要求

  • 5人
  • 首席医学官CMO

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业,总部位于杭州,下属有上海、南京、广州、武汉等多家分公司,同时自主开发国内领先的猎头办公系统及医药人才网站,全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台,在欧、美、日等国家建立了海归引进平台,同时积极开展医药高等院校公益系列讲座,搭建了以人力、企业为主体的立体化咨询服务网,为医药企业人才队伍建设发挥了积极重要作用,为很多医药企业解决了高端人力之困。

所在城市:
所任职位:
AC

企业信息

名称:
某生物医药公司
行业:
制药.生物
性质:
私营/民营企业
规模:
50-99人

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