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)