苏州招聘

工作职责:

Responsibility

? 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.

任职资格:

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。

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

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。