【Clinical Programmer有前途吗】辉瑞(中国)研究开

2020-05-04 体育在线新闻 阅读

  Clinical Programmer Clinical Programming and Writing Group

  POSITION SUMMARY

  Clinical Programmers in the Clinical Programming and Writing (CPW) Group of China R&D Center (CRDC) provide clinical programming support for various Pfizer global and regional clinical studies. They work closely with statisticians to implement analyses as specified in statistical analysis plans, table shells, and programming requirement documents. They are responsible for extracting data from databases to produce tables, graphs, analyses, and data listings based on clinical data, either for regulatory submission and reporting purposes for new drug application or for marketing support. They may also provide input and review for the activities of other statistics and clinical programming personnel, e.g. the review of Case Report Forms, protocols, statistical analysis plans, table shells, programming requirement documents, and databases in the future. Clinical programmers work primarily in the SAS programming language, and follow standardized quality control procedures for the development, testing (including peer review), and implementation of their programs. They work closely with colleagues in the Report Publishing Group to coordinate inclusion of components into clinical study reports.

  POSITION DETAILS

  Reports to: Supervisor / Manager of CPW, CRDC

  Department: CPW, CRDC

  Location: Shanghai

  KEY RESULT AREAS

  ? Perform activities and provide technical expertise in support of reporting data from clinical trials.

  ? Design and plan statistical algorithms and code in conformance with a globally aligned Systems Development Life Cycle (SDLC) and programming standards and within the applicable regulatory guidelines for the assigned clinical development programs for worldwide filings.

  ? Ensure that all programs, outputs and documentation are consistent with relevant ICH (eg. E6, E9, E10 etc) requirements and are conducted in compliance with relevant SOPs.

  ? Be accountable for implementation of statistical analyses, programmed outputs, and tables listings and graphs for integrated scientific reports for clinical trial results and support for publication activities, for assigned projects.

  ? Provide input into the design and development of project plans; in providing planning, development and delivery of analyses, (tables, listings and graphs), for use in scientific reports, clinical trial results, publications, regulatory response and commercialization.

  ? Implement global strategies, initiatives, processes, and standards to ensure speed and quality of fully integrated global data analyses on individual studies, submissions and other reporting of aggregated data.

  ? Ensure clear and timely communication with colleagues to enable improvements to be implemented during the study and also

  ? Liaise regularly with manager or other business owner to assess workload and priority activities and status of assigned tasks and projects.

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