Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
The Biostatistics Director is a core member of the Evidence Generation Team (EGT), support design, analysis, interpretation and reporting of clinical studies, regulatory submissions, Health Technology Assessments (HTA) and payer submissions, and dissemination of clinical data insights.
Responsibilities:
· Develop, lead, and serve as the primary point of contact for the statistical program strategy for a portfolio of products/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
Basic Qualifications:
· Doctorate degree and 4 years of Biostatistics experience
· OR
· Master’s degree and 8 years of Biostatistics experience
· OR
· Bachelor’s degree and 10 years of Biostatistics experience
Preferred Qualifications:
· Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research and
· 8+ years of post-graduate statistical experience in the pharmaceutical industry or medical research
· Statistical leadership / contribution to regulatory / reimbursement submissions
· Life Cycle Drug Development Experience
· Independent leadership of multiple projects
· Experience working effectively in a globally dispersed team environment with cross-cultural partners
· Excellent oral and written communication skills
· Thorough understanding of regulatory and industry trends
· Life Cycle Drug Development Experience
· Experience developing policies and SOPs
· Scientific research/publications in one or more areas of statistical science
· Prior experiences in metabolic diseases