The Biostatistic Manager will provide statistical contributions, statistical review and quality control of Study Outlines, protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) 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 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 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
Doctoral degree in Statistics/Biostatistics or other subject with high statistical content
Currently enrolled in PhD program in Statistics/Biostatistics or other subject matter with high statistical content, and must complete all requirements necessary to obtain Doctoral Degree in the PhD program prior to employment start date
Masters degree in Statistics/Biostatistics or other subject with high statistical content, and 3 years of directly related statistics experience
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
Masters degree in Statistics/Biostatistics or other subject with high statistical content, and 4 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 is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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