At Amgen, our shared mission—to serve patients—drives all that we do, and we are looking for a professional to contribute to the development of treatments that take care of others.
Requirements
- Doctorate degree Statistics/Biostatistics
- Master’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research experience
- Experience in machine learning, real world data analytics, electronic health record data analysis, clinical trial simulation or related applications
- Life-cycle drug development experience
- Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies
Responsibilities
- Provide statistical contributions, review, and quality control of study design documents, including Key Design Elements (KDE) and protocols
- Serve as the GBS lead on the Clinical Study Team leadership team to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives
- Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
- Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
- Ensure statistics sections of the TMF are maintained and up-to-date
- Communicate effectively with internal and external stakeholders regarding study-specific findings, analysis, and insights
- Contributes to defining signal detection threshold
Other
- Doctorate degree or Master’s degree or Bachelor’s degree or Associate’s degree or High school diploma / GED in statistics/Biostatistics or related subject
- 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research experience
- 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research experience
- 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research experience
- 10 years of post-graduate statistical experience in the pharmaceutical industry or medical research experience
