Biostatistician
上海康德保瑞医学临床研究有限公司
- 公司规模：150-500人
- 公司性质：合资(欧美)
- 公司行业：医疗/护理/卫生
职位信息
- 发布日期：2015-05-23
- 工作地点：北京
- 招聘人数：1
- 职位月薪：面议
- 职位类别：临床数据分析员
职位描述
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.
? 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.
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.
? 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.
公司介绍
WuXi PRA Clinical Research (Shanghai) Co., Ltd. offers comprehensive Phase I-IV clinical trial services in Mainland China, Hong Kong and the Asia region. With 5 offices and staff based in 17 cities across China, WuXiPRA’s locally based project teams operate with the support of PRA’s global resources, clinical research expertise, global technologies and SOPs. This centralized operational approach promotes higher quality and outstanding client service. WuXiPRA has invested significantly in staff focused on CFDA regulatory expertise, project management and clinical informatics resources, as well as other support services, including RPS embedded strategic outsourcing.
上海康德保瑞医学临床研究有限公司在中国内地、香港及亚洲地区提供全方位的I-IV期临床试验服务。 康德保瑞在中国有5个办公室，员工分布在17个城市，其团队拥有保瑞医药丰富的全球资源和临床研究专业知识以及全球化的技术和标准操作规程支持。这些有助于全球性、区域性以及本土的临床试验运作达到更高的质量。康德保瑞在人员方面投入巨大，主要集中在CFDA注册专业知识、项目管理、临床信息资源以及包括战略外包服务的其它支持服务方面。
上海康德保瑞医学临床研究有限公司在中国内地、香港及亚洲地区提供全方位的I-IV期临床试验服务。 康德保瑞在中国有5个办公室，员工分布在17个城市，其团队拥有保瑞医药丰富的全球资源和临床研究专业知识以及全球化的技术和标准操作规程支持。这些有助于全球性、区域性以及本土的临床试验运作达到更高的质量。康德保瑞在人员方面投入巨大，主要集中在CFDA注册专业知识、项目管理、临床信息资源以及包括战略外包服务的其它支持服务方面。