Biostatistics Sr. Mgr

The Senior Manager of Biostatistics independently leads a marketed product, and/or more complex studies and/or projects in nephrology and inflammation disease area, ensures that all statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct, influences and contributes to the development strategy, and defends statistical approaches internally and externally.

Amgen has a solid foundation in disease are of nephrology and inflammation and long-term commitment to patients by developing a whole new class of novel molecules - and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.

Department of Global Biostatistical Science (GBS) is at the center of this commitment to patient by introducing innovative study design and data analysis approach at Amgen. The nephrology and inflammation disease area in GBS is looking for a statistician who would work together to accomplish Amgen's commitment to patient in delivery of a marketed product and new innovative product

• 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 pediatric 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).

Basic Qualifications

Doctorate degree and 2 years of Biostatistics experience

OR

Master's degree and 6 years of Biostatistics experience

OR

Bachelor's degree and 8 years of Biostatistics experience

Preferred Qualifications

• Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
• Experience with inflammation disease is a plus
• Statistical leadership and contribution to regulatory or reimbursement submissions
• Experience working effectively in a globally dispersed team environment with cross-cultural partners

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

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.

MEANINGFUL IMPACT. To serve patients. We are all deeply committed to our mission: to serve patients. And we all have opportunities to contribute to that mission in meaningful ways. This creates a powerful sense of shared purpose.

INNOVATIVE: Stretch yourself at the cutting edge. You're poised to have a high impact in the new Bio century, Amgen offers our people interesting and challenging work.

REPUTATION. Be behind world-renowned products and services. With our industry reputation and strong product pipeline, you can take pride in working at Amgen.

COLLABORATIVE. Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success.

REWARDING. Get a fair share in success. Everyone's contribution is recognized - and strong performance is rewarded.

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.

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.