Amgen is looking to solve the business and technical problem of developing and executing statistical program strategies for a portfolio of complex programs, ensuring the highest statistical standards and integrity, and providing program-level statistical support for various evidence generation activities.
Requirements
- Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research
- At least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
- Master’s degree in Statistics/Biostatistics or related subject with high statistical content
- At least 10 years of post-graduate statistical experience in the pharmaceutical industry or medical research
- Doctorate in Statistics/Biostatistics and 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research in Oncology/ Hematology therapy area of at least 4 years
- Master’s degree and 12 years of Biostatistics experience in the pharmaceutical industry or medical research in Oncology/Hematology therapy area of at least 4 years
Responsibilities
- Develop, lead, and serve as the primary point of contact for the statistical program strategy for a portfolio of complex programs
- Influence across product life cycle through developing statistically compelling Evidence Generation Plans (EGP) in collaboration with Strategic Development Director, Director, Statistical Innovation, EDL, GDL, GMAL, and Regional Medical Leads
- Partner with evidence-related, cross-functional stakeholders to ensure the highest statistical standards and integrity and provide program level statistical support
- Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product
- Partner with CfDA Design & Innovation to drive novel designs and fit-for-purpose statistical approaches, standards, technical quality, study design, analysis, interpretation and evidence synthesis in balance with speed, quality, and cost for designated products / programs
- Oversee creation of Global Statistical Strategic Plan (GSSP) to align program design and statistical approaches with product strategy and EGP
- Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listings shells, submission data file specifications, and other key product-related documentation
Other
- Lead global biostatistics team
- Lead in the achievement of annual department goals
- Manage and develop staff
- Ensure Biostatistics team effectively utilize assigned supplier resources
- Oversee development of Amgen Policies, SOPs and other controlled documents
