长沙招聘

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.
? 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.


DECISION MAKING SCOPE

Financial

? Nil

Staffing

? The Clinical Programmer may coordinate contractors in analysis and reporting activities of data from one or more studies

Policy/Procedure

? Liaison of reviewing and developing all Clinical Programming and relevant policies and procedures, and responsibility for compliance of the department with all corporate standards, policies and procedures.


ESSENTIAL REQUIREMENTS

Education

? At least bachelor degree or equivalent in statistics, computer science, or a mathematical science
? Master's Degree preferred


Experience经验要求

? 3 years relevant experience with SAS programming in clinical development
? Some clinical development and business experience in order to have an understanding of the processes associated with clinical and regulatory operations.
? Experience supporting regulatory submissions
? 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.

Key Competencies
? Strong understanding of the current technologies and global Analysis and Reporting environments to utilize them for efficient delivery of programming outputs.
? Expertise in the SAS programming language.
? Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
? Basic knowledge to use Windows OS, MS-Word, MS-Excel, E-Mail (MS-Outlook).
? Ability to write clear, well documented, and standardized computer programs.
? A readiness and ability to work to pre-defined programming standards.
? Strong analytical skills.
? Able to work on multiple projects simultaneously.
? Demonstrated platform skills. Experience in presenting to science and non-science audiences.
? Demonstrated effective written communication skills
? Capability to communicate effectively in English, both verbally and written.
? May oversee contractors
? Must be accurate and have an excellent attention to detail and a quality control approach to work.
? Ability to work effectively in a multi-cultural context
? Ability to work effectively in a matrix organization
? Utilizes and shares innovative approaches to build and maintain a competitive advantage
? Looks for opportunities for collaboration and acts upon them
? Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards.
? Contributes to a learning organization, encouraging experimentation, risk-taking, and development in all aspects of work performance.

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。