Senior Director, Biostatistics

Career Category

Job Description

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 ever-better products that reach over 10 million patients worldwide. It’s 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 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 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/programs
• Influence 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 Leads
• Partner with evidence-related, cross-functional stakeholders to ensure the highest statistical standards and integrity and provide program level statistical support

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 including phase 3 drug development in metabolic diseases or cardiovascular outcome trials (CVOT)
• and
• 10+ 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
• Life Cycle Drug Development Experience
• Experience developing policies and SOPs
• Scientific research/publications in one or more areas of statistical science

Thrive

What 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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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 plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.

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