生物统计师
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上市申办方
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上海 北京
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30K - 60K 14薪
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硕士研究生
关于客户
国资背景的上市企业。
统计团队10人左右。
职位描述
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1. Actively participate in and contribute to decision making related to clinical development strategies and regulatory strategies.
2. Negotiate timelines (statistical) at study/indication level.
3. Play a leadership role in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
4.Oversee definition and implementation of compound-level database (including ADaM datasets), analysis and reporting standards.
5. Coordinate with Data management, Programming CRO, Clinical to target high quality databases and specifications at compound level
6. Provide study level analytical oversight of plan and ensure timelines and achieve high quality statistical outputs.
7.Interact with external statistical experts for issues related to study design, methodology and results.
8. Monitor industry advances and FDA/CDE guidance documents in statistical methods to optimize study designs and statistical analysis methods and implement innovative approaches at a compound level.
任职要求
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Master or Ph.D. in Biostatistics or a relevant field.
如果您对于上述职位感兴趣,欢迎您邮件联系wang.yaqi@fatalent.com 或者来电咨询15618040323
Reference Number: 15618040323
Contact Details: wang.yaqi@fatalent.com