WHAT YOU WILL DO
Let’s do this. Let’s change the world. In this vital role you will leads projects and studies, ensuring all statistical aspects pertaining to clinical activities meet required standards and are statistically correct while influencing study design, defending statistical approaches and adhering to Amgen Policies, SOPs and other controlled documents.
- Provide statistical contributions, statistical review and quality control of Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications and other communications.
- Complete statistical analysis of individual studies/projects.
- Publish applied research in scientific journals and books, making presentations on statistical methodology in the biopharmaceutical setting at external scientific functions such as biopharmaceutical industry and academic meetings.
- Keep full knowledge of Amgen’s statistical policies and strategies.
- Stay abreast of the latest developments in the field of statistics in drug development and contributing to scientific advances in the field.
- Communicate the role of the Global Biostatistics department within the company and contributing to statistical training.
- Assist in the reviews of Amgen Policies, SOPs, controlled documents and study and systems audits conducted by Amgen CQA and external bodies.
- Serve as team member of change / process improvement initiatives.
WHAT WE EXPECT OF YOU
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go-getter with these qualifications.
- Doctorate degree OR
- Master’s degree and 3 years Statistics/Biostatistics experience OR
- Bachelor’s degree and 5 years Statistics/Biostatistics experience OR
- Associate’s degree and 10 years Statistics/Biostatistics research experience Or
- High school diploma / GED and 12 years of Statistics/Biostatistics experience
- Doctoral degree in Statistics/Biostatistics or other subject with high statistical content