Career Category

Job Description

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)