Statistician 生物统计师
上海罗氏制药有限公司上海总部
- 公司规模:1000-5000人
- 公司性质:合资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2013-10-14
- 工作地点:上海
- 招聘人数:1
- 工作经验:二年以上
- 学历要求:硕士
- 语言要求:英语熟练
- 职位类别:临床数据分析员 统计员
职位描述
·Provide statistical expertise to local data generation program including sponsored trials and supported trials
- Early involvement in the study synopsis discussion by providing statistical considerations with various statistical methodology
- Be responsible for the statistical part for local sponsored trial, including statistical section in the protocol, input to CRF, database design, data cleaning plans, statistical analysis plan, statistical analysis
- Act as local contact person to talk with GMA wherever statistical expertise is needed
- Review and approval of any statistical related documents if an external CRO is involved in providing DM/statistical service to local trials
- Work with project leader on the risk mitigation/contingency plan with statistical expertise
- Provide statistical advice to local supported trials when appropriate
·Work with Medical Manager to maximize product value by providing statistical input in data interpretation of Roche/competitors’ clinical trial result
- Provide statistical expertise in the data interpretation for both internal & external study results
- Involved in the risk/benefit discussion when new data emerges
·Act as internal consult to provide technical expertise
- Training to medical colleagues on the statistical basics
- Training to external investigators on the statistical basics when appropriate
- Training to external doctors on the statistical basics when is needed for defending Roche products
·Maintain process standards across the therapeutic areas according to Roche SOPS, China SFDA requirements and ICH guidelines with regard to statistics
·Lead a small team to provide Stat & Data Management service as needed
- Be responsible for the delivery of the whole team
- Be responsible for the development of the team members, including recruitment, setting up annual objective & personal development plan, provide coaching and on job training to the team members
- Determine and control all aspects of the team budgets and ensure that annual and phased budge are achieved
Qualification and Experience
1.College degree or above in biomedical/life science, biometrics, public health, or other related major
2.Prerequisite qualifications for employment as Biostatistician for pharmaceutical R&D or Medical
2-3 years’ experience to work as Biostatistician in multinational pharmaceutical company or Clinical Research
Organization, experience in oncology trials is mandatory
3.Application of a wide variety of statistical techniques in clinical development
4.SAS programming
5.Business acumen
6.Be able to handle technical discussion in English
公司介绍
我们始终以患者为中心,致力于帮助患者从根本上延长生命和改善生活质量。目前,罗氏在华拥有16个产品,覆盖8个治疗领域。我们与政府、医疗机构以及非政府组织等社会各界多方携手,共同探索创新的合作模式,通过一系列有影响力和可持续的举措惠及更多的中国患者。
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联系方式
- 公司地址:龙东大道1100号