招聘人数：3 人
性别要求：不限性别
POSITION SUMMARY 职位概要
Clinical Programmers in the Clinical Programming an d Writing （CPW） Group of China R&D Center （CRDC） provide clinical programming support for various Pfizer global an d regional clinical studies. They work closely with statisticians to implement analyses as specified in statistical analysis plans, table shells, an d programming requirement documents. They are responsible for extracting data from databases to produce tables, graphs, analyses, an d data listings based on clinical data, either for regulatory submission an d reporting purposes for new drug application Ｏr for marketing support. They may also provide input an d review for the activities of other statistics an d clinical programming personnel, e.g. the review of Case Report Forms, protocols, statistical analysis plans, table shells, programming requirement documents, an d databases in the future. Clinical programmers work primarily in the SAS programming language, an d follow standardized quality control procedures for the development, testing （including peer review）, an d implementation of their programs. They work closely with colleagues in the Report Publishing Group to coordinate inclusion of components into clinical study reports.
临床数据程序员服务于辉瑞中国研发中心临床数据程序及报告撰写部，为辉瑞全球和各地区的临床研究项目提供数据分析编程支持。临床数据程序员与统计人员密切合作, 根据统计分析计划﹑报表模版及程序要求文件进行分析。临床数据程序员负责提取数据库数据以生成报表﹑图表﹑分析和临床数据列表，为新药注册报批申请和市场活动提供支持。同时，该职位将来可能对其他统计或临床数据程序人员的工作提供建议和检查，如：病历报告表格﹑临床试验方案﹑统计分析计划﹑报表模版﹑编程要求文件及数据库进行检查。临床数据程序员主要运用SAS语言进行编程，并遵循标准质量控制流程进行程序开发﹑测试（包括第二者程序检查）及程序运行。临床数据程序员将与临床报告编辑部门紧密合作，负责协调将编程产生的结果整合进入临床试验报告。
Reports to: Manager of Wuhan CPW, CRDC临床数据及报告撰写部经理（武汉），中国研发中心Department: Wuhan CPW, CRDC临床数据及报告撰写部（武汉）, 中国研发中心
KEY RESULT AREAS
Perform activities an d provide technical expertise in support of reporting data from clinical trials.Design an d plan statistical algorithms an d code in conformance with a globally aligned Systems Development Life Cycle （SDLC） an d programming standards an d within the applicable regulatory guidelines for the assigned clinical development programs for worldwide filings.Ensure that all programs, outputs an d documentation are consistent with relevant ICH （eg. E6, E9, E10 etc） requirements an d are conducted in compliance with relevant SOPs.Be acＣountable for implementation of statistical analyses, programmed outputs, an d tables listings an d graphs for integrated scientific reports for clinical trial results an d support for publication activities, for assigned projects.Provide input into the design an d development of project plans; in providing planning, development an d delivery of analyses, （tables, listings an d graphs）, for use in scientific reports, clinical trial results, publications, regulatory response an d commercialization.Implement global strategies, initiatives, processes, an d standards to ensure speed an d quality of fully integrated global data analyses on individual studies, submissions an d other reporting of aggregated data.Ensure clear an d timely communication with colleagues to enable improvements to be implemented during the study an d alsoLiaise regularly with manager Ｏr other business owner to assess workload an d priority activities an d status of assigned tasks an d projects.Ensure timely delivery of outputs to meet study timelines an d quality expectationsWork with manager Ｏr other CRDC management （if necessary） to give input to project plans an d to implement resource strategies to achieve CRDC goals.Provide regular feedback as to the efficiency an d effectiveness of current procedures/jobs to manager.
Personal Development:Attend an d actively participate in personal development courses as required.Attend Pfizer in house training an d workshops.Develop an d maintain competence in SAS programming an d other related tools.
ESSENTIAL REQUIREMENTS
Education学历要求
At least bachelor degree Ｏr equivalent in statistics, mathematical science, biostatistics, pharmacology Ｏr public health统计学,数学,生物统计,药学,公共卫生相关领域大学本科及以上Master s Degree preferred硕士学位优先考虑
Experience preferred有以下经验优先考虑1 years relevant experience with SAS programming in clinical development具备一年临床研发领域的SAS编程经验Some clinical development an d business experience in order to have an understanding of the processes associated with clinical an d regulatory operations.有临床开发与药品业务方面经验，了解临床和新药开发的相关程序。Experience supporting regulatory submissions具备协助新药申报的工作经验Extensive knowledge of computer systems, operating systems an d analysis an d reporting environments used in the support of clinical programs an d the development of software via structured SDLC.拥有广泛的电脑系统﹑操作系统和用于支持临床项目的分析报告环境以及通过SDLC进行软件开发等方面的知识。
Key Competencies技能要求Strong understanding of the current technologies an d global Analysis an d Reporting environments to utilize them for efficient delivery of programming outputs.熟悉医药科技现状和全球数据分析及报告系统，以有效的进行数据编程。Expertise in the SAS programming language.精通SAS编程语言Effective verbal an d written communication skills in relating to colleagues an d associates both inside an d outside the organization具备对内/对外及同事间有效的口头和书面沟通技巧Basic knowledge to use Windows OS, MS-Word, MS-Excel, E-Mail （MS-Outlook）.能够运用视窗操作系统，Word, Excel, OutlookAbility to write clear, well documented, an d standardized computer programs.能够编写清晰标准，文档完整的计算机程序A readiness an d ability to work to pre-defined programming standards.具备按已定义的编程标准进行工作的能力Strong analytical skills.具备很强的分析能力Able to work on multiple projects simultaneously.具备同时进行多个项目工作的能力Demonstrated platform skills. Experience in presenting to science an d non-science audiences.具备良好的基础能力，拥有面对学术和非学术听众的演讲经验Demonstrated effective written communication skills良好的书写能力进行有效的演示Capability to communicate effectively in English, both verbally an d written.能够熟练运用英语进行书面和口头的有效沟通May oversee contractors可能对外包服务进行监督Must be accurate an d have an excellent attention to detail an d a quality control approach to work.必备高度精确性，非常关注细节，及质量控制的工作方式Ability to work effectively in a multi-cultural context能够在多文化氛围下高效工作Ability to work effectively in a matrix organization能够在矩阵组织中工作Utilizes an d shares innovative approaches to build an d maintain a competitive advantage利用并分享创新的方案来建立和保持竞争优势Looks for opportunities for collaboration an d acts upon them主动寻找合作机会并采取相应行动Respectfully challenges practices, decisions Ｏr ideas to uphold integrity an d ethical standards.以尊重的态度来挑战日常实践操作和决定以保证完整性和符合规范Contributes to a learning organization, encouraging experimentation, risk-taking, an d development in all aspects of work performance.愿意为一个学习型组织工作，鼓励进行尝试，承担风险，并在工作绩效的各方面寻求进步
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