Job Information
Amgen Biostatistics Manager in Shanghai, China
The Biostatistics Manager at Amgen leads the biostatistics team in designing and implementing the statistical component of clinical trials. They are responsible for ensuring the quality of statistical methods and for collaborating with cross-functional teams for analysis and reporting.
The Biostatistics Manager will
Provide 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
Publish 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 Amgen 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
Basic Qualifications
- Doctoral degree in Statistics/Biostatistics or other subject with high statistical content
Preferred Qualifications:
Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 1 or 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research
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)
Amgen
- Amgen Jobs