Senior Director, Biostatistics
3 months 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/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 supportBasic Qualifications:
- Doctorate degree and 4 years of Biostatistics experience
- OR
- Masters degree and 8 years of Biostatistics experience
- OR
- Bachelors 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)
- 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 scienceThrive
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.
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 possibleApply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
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.
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