赛纽仕医药咨询(上海)有限公司

(Sr.) Statistical Programmer

Shanghai, Shanghai, CN

about 1 year ago
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Summary

该职位来源于猎聘 The key responsibilities of this role include but not limited to: ? Providing technical and project management leadership in analytical programming and application (SAS) designed to analyze and report complex clinical trial data and for electronic regulatory submissions and filings ? Collaborating efficiently and effectively with cross-functional team members on clinical trials, closely with statisticians to ensure timely deliverables with high quality, e.g. SDTM and ADaM datasets, statistical analysis results of clinical trials and integrated analyses cross trials. ? Participating in technical meetings for internal and external representatives (e.g., CROs, Clinical Development Partners, vendors, regulatory agencies, etc.)

  • Participating on high impact departmental and cross-functional teams working on standard operating procedures, process improvements, system validation, customization, and integration of new tools and technologies ? Supporting the China Programming head to establish a high performing team of statistical programmers Experience Requirements: ? Master degree or equivalent. 3-5 years of experience in statistical programming in the pharmaceutical industry, oncology therapeutic area preferred ? proven solid technical skills for clinical drug development
  • Proven experience with SDTM and ADaM developments ? Proven experience all SAS language, procedures, and options commonly used in clinical trial report including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH ? Understanding of relevant regulatory guidelines, GCP and industry standards and practices regarding data management, China eSub requirement and data requirement from HGRAG if needed ? Refined oral and written communication skills, including effective negotiation, influencing, and active listening and strong customer focus
  • Having experience on supporting global/regional filings for at least a MRCT study ? Fluent in both Chinese & English ? Understanding of Chinese Culture

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