南平招聘

职位职能: 临床数据编程员
职位描述:
Clinical Programming and Writing Group
临床数据程序及报告撰写部

辉瑞（武汉）研发中心向社会公开招聘临床数据程序员若干名（工作地点：武汉）

如果您符合以下任一要求，并有兴趣长期在生物制药行业全球领先的辉瑞公司武汉研发中心开拓职业发展机会的话，欢迎您第一时间申请我们的岗位.
1. 现在已经是临床数据程序员，或从事临床试验相关工作；
2. 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；
3. 有海外的相关领域学习或工作背景；

POSITION SUMMARY 职位概要

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.

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 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.
Ensure timely delivery of outputs to meet study timelines and quality expectations
Work with manager or other CRDC management (if necessary) to give input to project plans and to implement resource strategies to achieve CRDC goals.
Provide regular feedback as to the efficiency and effectiveness of current procedures/jobs to manager.

Personal Development:
Attend and actively participate in personal development courses as required.
Attend Pfizer in house training and workshops.
Develop and maintain competence in SAS programming and 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 and business experience in order to have an understanding of the processes associated with clinical and 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 and analysis and reporting environments used in the support of clinical programs and 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 and global Analysis and 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 and written communication skills in relating to colleagues and associates both inside and 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, Outlook
Ability to write clear, well documented, and standardized computer programs.
能够编写清晰标准，文档完整的计算机程序
A readiness and 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 and 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 and 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 and have an excellent attention to detail and 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 and shares innovative approaches to build and 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 and 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 and 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, and 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

简历收集邮箱：chinacpwtalent@pfizer.com

辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球***的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.