长沙招聘

职位描述：

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。

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，应届生2016年亦可申请。

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

举报 分享

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。