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雇主是一家欧洲的制药公司,不大,但在其专注学术领域有很好建树,主要是专注在多肽类生物药品,治疗领域主要是大内科等一些罕见病,例如克罗恩病,中枢性尿崩症,和一些肿瘤的生物用药,以及辅助生殖技术试管婴儿用药.2010年进入中国,11年北京成立亚太研发中心.
目前在北京亚太研发中心招聘一名统计的Leader,辅助雇主在中国区所有的统计事务,并搭建其统计团队。汇报给亚太研发中心Head(丹麦人)
如果你愿意就这个职位和我联系,我的联系方式:
Tel:0086-20-22372809
MP:0086-138-2449-1073
或者邮箱:charles-cui#synergychina.net(#改成@)
要求:统计学博士以上学历,如果经验丰富可以放宽到硕士,英文口语流利,3年以上生物统计工作经验。
工作职责:
1. To Establish the Biometric function in China Development, ensuring to the same level of standards as Global Biometrics.
2. To manage one data manager.
3. To stay updated on relevant statistical methodology and tools.
4. Be aware and updated of any specific guidelines and/or practices most suitable to the Chinese requirements to facilitate and accelerate the registration of products.
5. Contribute to clinical development programs &study designs for the development candidates assigned to China Development.
6. Act as a trial-statistician (responsible for study design, statistical section of synopsis/protocol, statistical analysis plan, performing analyses, statistical reports, clinical study reports).
7. Act as a randomisation-statistician, if it required
8. To build a network of statistical experts to facilitate the relationship with the Chinese Authorities (CFDA ) and to participate in the agency meetings, if required
9. To co-ordinateevaluation and selection of qualified biometric CROs in China for outsourcing. To act as a project co-ordinator to ensure efficient CRO management and validation of statistical tasks of the clinical trials
10. Participate in, or initiate other tasksassigned e.g. writing or updating SOPs
11. As a member of FerringGlobal Biometrics, to work on the projects/clinical trials assigned by the Global Biometrics, if required
12. Actively participate in regular global biostatistics meetings e.g. presenting diverse statistical issues for discussion
13. To coach statisticians/statistical programmers assigned to the project(s) (share and provide sufficient biostatistical/clinical context/knowledge, provide clarity on tasks, etc)
14. Shared responsibility for SAS global database (dynamic repository) in SDD
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