Senior Director, Biostatistics
3 weeks ago
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
The Senior Director in Biostatistics 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:
Oversee large and/or complicated product(s) or indication(s), which may require overseeing other Global Statistical Lead(s).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, Statistical Innovation, EDL, GDL, GMAL, and Regional Medical LeadsPartner 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 experienceORMasters degree and 8 years of Biostatistics experienceORBachelors degree and 10 years of Biostatistics experiencePreferred Qualifications:Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research including phase 3 drug development in metabolic diseases or cardiovascular outcome trials (CVOT)and10+ 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 trendsLife Cycle Drug Development ExperienceExperience developing policies and SOPsScientific research/publications in one or more areas of statistical scienceThriveWhat you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #obesity-
Biostatistics Director
3 weeks ago
Washington, Washington, D.C., United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...
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Washington, Washington, D.C., United States The George Washington University Full timeJob OverviewPosition Summary:The Biostatistics Center at the Milken Institute School of Public Health, part of George Washington University, is a prominent off-campus medical research facility located in Rockville, Maryland. This center plays a crucial role in coordinating extensive multi-center clinical trials and epidemiological studies funded by federal...
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