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The Biostatistics Manager will
 rovide statistical contributions, statistical review and quality control of Study Outlines, protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Figure and Listing (TFL) shells, analysis data specifications, other key-study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications
Contribute to the exploratory analyses of existing databases in support of the publications and commercialization of existing Amgen products
Work with the statistical programmers to complete statistical analysis of individual studies/projects/publications
ublish applied research in scientific journals and books, and give presentations on statistical methodology within Amgen and/or in the biopharmaceutical setting at external scientific meetings
Be familiar with statistical policy and strategy at Amgen and assist in the review of company Policies, SOPs and other controlled documents
Contribute to process improvement and good practices initiatives
Communicate the role of the Global Biostatistics department, and may contribute to statistical training within Global Biostatistics and within Amgen
Preferred Qualifications:
Designing, analyzing and/or reporting clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
Life-Cycle Drug Development Experience (Clinical Development and Post-marketing)
Leadership of at least 1 study/project with minimal oversight
Authored a clinical trial or observational study protocol, DRT/DMC charter, statistical analysis plan, clinical study report, and/or manuscript of clinical trial or observational study results
Knowledge of fundamentals of project planning
Effective communication of written and oral statistical information and clinical trial or observational study results
Communication of statistical information (written and oral)
Demonstrated effective communication skills (written and oral)
The JD is a gerneral description, The title is flexible based on your backgound. If you need more information, please feel free to call Mary +86 1822192157 or email 18221921057@163.com . Btw, if you used wechat, please add me as friends, my ID is 18221921057. thanks. |
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发表于 2017-5-3 16:55:55