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Amgen
Washington, DC, United States
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 together researching, manufacturing, and delivering ever-better
Job Source: AmgenAmgen
Washington, DC, United States
In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of CfDA (Center for Design & Analysis). The Biostatistics Senior Manager independently leads multiple studie
Job Source: AmgenAmgen
Washington D.C.
**HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ev
Job Source: AmgenAmgen
Washington D.C.
**HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ev
Job Source: AmgenAmgen
Washington, DC, United States
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
Job Source: AmgenEdwards Lifesciences Corp
Washington, DC, United States
Manager Biostatistician - Transcatheter Mitral & Tricuspid Therapies (Remote- US) This is an exciting opportunity for an exceptional biostatistician professional with extensive experience to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up. TMTT is dedicated to solving the complex challenges of mi
Job Source: Edwards Lifesciences CorpEmmes
Rockville, MD, United States
Overview Head of Biopharma Biostatistics US Remote TheEmmesCompany, LLC(“Emmes”) isa global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our companyEmmes, which means truth.Through deca
Job Source: EmmesAmgen
Washington, DC, United States
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
Job Source: AmgenWashington, DC, United States
Biostatistics Manager
WHAT YOU WILL DO
Lets do this. Lets change the world. In this vital role you will achieve results through detailed goalsetting, accountability measures, effective partnership, performance management, collaborationwith other groups and a dedication to serving customers, both inside and outside of, CfDA (Centerfor Design & Analysis). The Biostatistics Manager independently leads sophisticated studies in theGeneral Medicine therapeutic areas (Cardiometabolic, Inflammation, Nephrology, andNeuroscience), ensuring that the statistical aspects of clinical activities meet required standards andare robust and valid. Will also influence and supply to strategy development, defend statisticalapproaches and represent GBS (Global Biostatical Science) through participating in andcollaborating with multidisciplinary study teams.
WIN
WHAT WE EXPECT OF YOU
We are all different, yet we all use our outstanding contributions to serve patients. The professionalwe seek is proficient with these qualifications.
Key activities include:
Providing statistical contributions, statistical review, and quality control of Key DesignElements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs),Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key study related documentation, protocol deviations, Flash Memos, Clinical Study Reports(CSRs), clinical publications, and other communications
Completing statistical analysis of individual studies/projects
Publishing applied research in scientific journals and books, and give presentations onstatistical methodology in the biopharmaceutical setting at external scientific meetings(biopharmaceutical industry and academic meetings)
Being familiar with statistical policy and strategy at Amgen
Staying abreast of the latest developments in the field of statistics in drug development andcontribute to scientific advances in the field
Communicating the role of the Global Biostatistics department, and may contribute tostatistical training within Global Biostatistics and within Amgen
Assisting in the review of Amgen Policies, SOPs, and other controlled documents
Assisting with study and systems audits conducted by Amgen CQA and external bodies
Serving as team member of change / process improvement initiatives
BASIC QUALIFICATIONS:
Doctorate degree OR Masters degree and 3 years of experience OR
Bachelors degree and 5 years ofexperience OR Associates degree and 10 years of experience OR High school diploma / GED and 12 years ofexperience
PREFERRED QUALIFICATIONS:
Doctorate degree in statistics or biostatistics
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Email Alert for Biostatistics Manager jobs in Washington, DC, United States
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