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Dir Biostatistics

Employer
Amgen
Location
Thousand Oaks, CA, US
Start date
Feb 11, 2019

View more

Discipline
Science/R&D, Biostatistics
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Beach, Best Places to Work

Job Details

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

Provide statistical leadership to Centralised Statistical Monitoring and Quality Tolerance Limit projects

Provide statistical oversight of the safety reporting activities supporting the IND final rule

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

Experience developing policies and SOPs

Scientific research/publications in one or more areas of statistical science
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen 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.

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.

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
United States

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