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liuchongyuͳæ (СÓÐÃûÆø)
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¸ø³æÓÑ·¢¸£ÀûÁË£¬»ÔÈðÖÆÒ©ÖйúÑо¿¿ª·¢ÓÐÏÞ¹«Ë¾ÄÚ²¿ÕÐÆ¸Ö°Î»Clinical Programmer£¨Îä&
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ְλÃû³Æ/Position Title Clinical Programmer(8 vacancies) ²¿ÃÅ/Department Clinical Programming and Writing Group (CPW), CRDC »ã±¨ÈË/Reporting to Hu Dian, Manager, Clinical Programming and Writing ¹¤×÷³ÇÊÐ/Location Wuhan ½ØÖ¹ÈÕÆÚ/Deadline October 31,2012 ÔðÈÎ POSITION DESCRIPTION Clinical Programmer Clini cal Programming and Writing Group POSITION SUMMARY Clinical Programmers in the Clinical Programming and Writing (CPW) Group of Ch ina 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, a nd programming requirement documents. They are responsible for extracting data from databases to produce tables, graphs, analyses, and data listings based o n clinical data, either for regulatory submission and reporting purposes for n ew drug application or for marketing support. They may also provide input and review for the activities of other statistics and clinical programming personn el, e.g. the review of Case Report Forms, protocols, statistical analysis plan s, table shells, programming requirement documents, and databases in the futur e. Clinical programmers work primarily in the SAS programming language, and f ollow standardized quality control procedures for the development, testing (in cluding peer review), and implementation of their programs. They work closely with colleagues in the Report Publishing Group to coordinate inclusion of comp onents into clinical study reports. POSITION DETAILS Reports to: Manager of Wuhan CPW, CRDC Department: Wuhan CPW, CRDC KEY RESULT AREAS • Perform activities and provide technical expertise in support of repor ting data from clinical trials. • Design and plan statistical algorithms and code in conformance with a globally aligned Systems Development Life Cycle (SDLC) and programming standar ds and within the applicable regulatory guidelines for the assigned clinical d evelopment programs for worldwide filings. • Ensure that all programs, outputs and documentation are consistent wit h relevant ICH (eg. E6, E9, E10 etc) requirements and are conducted in complia nce 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 pr ojects. • Provide input into the design and development of project plans; in pro viding planning, development and delivery of analyses, (tables, listings and g raphs), for use in scientific reports, clinical trial results, publications, r egulatory response and commercialization. • Implement global strategies, initiatives, processes, and standards to ensure speed and quality of fully integrated global data analyses on individua l studies, submissions and other reporting of aggregated data. • Ensure clear and timely communication with colleagues to enable improv ements to be implemented during the study and also • Liaise regularly with manager or other business owner to assess worklo ad 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 inpu t to project plans and to implement resource strategies to achieve CRDC goals. • Provide regular feedback as to the efficiency and effectiveness of cur rent procedures/jobs to manager. Personal Development: • Attend and actively participate in personal development courses as req uired. • Attend Pfizer in house training and workshops. • Develop and maintain competence in SAS programming and other related t ools. ESSENTIAL REQUIREMENTS Education • At least bachelor degree or equivalent in statistics, computer science , or a mathematical science • Master's Degree preferred Experience • 3 years relevant experience with SAS programming in clinical developme nt • Some clinical development and business experience in order to have an understanding of the processes associated with clinical and regulatory operati ons. • Experience supporting regulatory submissions • Extensive knowledge of computer systems, operating systems and analysi s 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 a nd Reporting environments to utilize them for efficient delivery of programmin g outputs. • Expertise in the SAS programming language. • Effective verbal and written communication skills in relating to colle agues and associates both inside and outside the organization • Basic knowledge to use Windows OS, MS-Word, MS-Excel, E-Mail (MS-Outlo ok). Word, Excel, Outlook • Ability to write clear, well documented, and standardized computer pro grams. • 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 wr itten. • May oversee contractors • Must be accurate and have an excellent attention to detail and a quali ty 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 comp etitive advantage • Looks for opportunities for collaboration and acts upon them • Respectfully challenges practices, decisions or ideas to uphold integr ity and ethical standards. • Contributes to a learning organization, encouraging experimentation, r isk-taking, and development in all aspects of work performance. ÇëͶµÝÖÐÓ¢ÎļòÀú£¬¼òÀúͶµÝÓÊÏ䣺pfizerhr@sina.cn [ Last edited by liuchongyu on 2012-8-16 at 21:37 ] |
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