Thousand Oaks, CA, United States
Sciences, Executive, Manager, Pharmaceutical
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 medicalneed and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people\u2019s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world\u2019s 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\/programsInfluence 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 supportBasic Qualifications:Doctorate degree and 4 years of Biostatistics experienceORMaster\u2019s degree and 8 years of Biostatistics experienceORBachelor\u2019s degree and 10 years of Biostatistics experiencePreferred 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 researchStatistical leadership \/ contribution to regulatory \/ reimbursement submissionsLife Cycle Drug Development ExperienceIndependent leadership of multiple projectsExperience working effectively in a globally dispersed team environment with cross-cultural partnersExcellent oral and written communication skillsThorough understanding of regulatory and industry trendsExperience developing policies and SOPsScientific research\/publications in one or more areas of statistical scienceAmgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Website : http://www.amgen.com
Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses.