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Biostatistics Manager

Employer
Amgen
Location
Washington D.C., District of Columbia
Start date
Jun 16, 2024

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Discipline
Science/R&D, Biostatistics
Required Education
High School or equivalent
Position Type
Full time
Hotbed
Best Places to Work

Job Details

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

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
US

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