Amgen Biostatistics Senior Manager in Washington D.C., District Of Columbia
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. Join us.
Senior Manager Biostatistics
What you will do
The Senior Manager of Biostatistics is an exciting opportunity depending on your level of experience located in our Thousand Oaks Office. In this role, you will hold the chance to utilize your statistical expertise in the design, analysis, and interpretation of clinical trial programs; submission and defense of regulatory filings; and the generation of evidence to support product commercialization and reimbursement. You also will have the opportunity to lead and direct elements of project work.
The person is expected to independently lead a complex study and/or projects and lead the development of new indication under the supervision of Director in biostatistics in General Medicine / Inflammation disease area, to ensures that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct, to influences and contributes to the development strategy, and to defend statistical approaches internally and externally.
Main responsibility includes.
Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge of cross-functional areas to inform and provide sound statistical guidance to teams in clinical development, filing, marketing support and medical science activities.
Implements, oversees and supports standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
Plans and executes statistical contributions to protocols, Flash Memos, and Clinical Study Reports (CSRs).
Provides statistical inputs to clinical publications, Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents.
Oversees statistical work performed by study statisticians.
Performs statistical analysis of multiple studies/projects and subsequent exploratory analyses and makes sound conclusions and recommendations.
Proactively anticipates and communicates resource and quality issues that may impact deliverables or timelines within functional area as well as cross-functionally.
Be familiar with statistical policy and strategy at Amgen; having working knowledge of theoretical and applied statistics and of regulatory guidelines.
Stays abreast of latest developments in the field of statistics in drug development (innovative trial design), Contributes to process improvement and operational efficiency.
Adheres to all Amgen Policies, Standard operation procedures (SOPs).
Doctorate degree and 2 years of experience
Master’s degree and 6 years of experience
Bachelor’s degree and 8 years of experience
Associate’s degree and 10 years of experience
High school diploma / GED and 12 years of experience
Technically strong with hands on experience of various design and statistical analysis
Any clinical trial experience and experience in inflammation disease is a plus
Experience working effectively in a globally dispersed team environment with cross-cultural partners
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Equal Opportunity Statement
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 a 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 an accommodation.