长沙招聘

General Summary

Plays a functional lead role in the design, analysis, and reporting of clinical studies. Writes statistical analysis plans, performs statistical analyses, contributes to study reports, and interacts with other study team members and clients on study set up and conduct, including timelines and financial oversight.

 

Accountabilities

Develops statistical analysis plans and reporting specifications for simple clinical studies.

• Develops and describes appropriate statistical techniques for the analysis of data in a statistical analysis plan.

• Works with other statisticians on statistical methodology, study design, therapeutic area details, and data analysis.

• Design appropriate shells and specifications for outputs.

Performs statistical analyses and interprets results for simple clinical studies.

• Develops or QCs analysis programs to implement techniques described in the statistical analysis plan.

• Approves final database for freeze/lock.

• Assesses model assumptions for statistical analyses.

• Works with programmers, writers, and clinicians to coordinate data summarization and analysis activities, including summary statistics, tabulations, graphics, analysis output, and raw data listings.

• Develops statistical reports and statistical sections of clinical study reports.

Contributes statistical expertise to project teams for the design, analysis, and reporting of simple clinical studies.

• Serves as primary functional representative on project teams.

• Provides input into the preparation and review of clinical study protocols.

• Creates dummy and final randomization schemes for clinical studies.

• Participates in the development and review of CRFs, data edit specifications, and critical variable lists.

• Works with the project manager and functional manager to determine resource projections and project schedules.

• Visits clients to discuss statistical issues.

Maintains, develops, and shares knowledge of company and industry procedures and methodologies.

• Performs billable work in accordance with WuXiPRA’s policies, procedures, and SOPs.

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• Maintains solid knowledge of drug development process.

• Maintains solid knowledge of SAS procedures and good programming practices.

• Continues statistical training on new methods and techniques via self-study, internal training and courses, and external conferences and courses.

• Develops knowledge of FDA and EMEA guidelines and requirements for reporting of clinical trials data.

   

Qualifications

• MS degree in statistics or biostatistics

• Demonstrated expertise in multiple statistical areas

• Demonstrated ability to plan, implement, and monitor the statistical processes for clinical studies

• Excellent written and oral communication skills; Read, write and speak English.

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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。