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Amgen
Washington D.C.
In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of CfDA (Center for Design & Analysis). The Biostatistics Senior Manager independently leads multiple studie
Job Source: AmgenAmgen
Washington D.C.
**HOW MIGHT YOU DEFY IMAGINATION?** You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s lea
Job Source: AmgenAmgen
Washington D.C.
**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 e
Job Source: AmgenAmgen
Washington, DC, United States
In this vital role you will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups and a dedication to serving customers, both inside and outside of CfDA (Center for Design & Analysis). The Biostatistics Senior Manager independently leads multiple studie
Job Source: AmgenAmgen
Washington D.C.
**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 ev
Job Source: AmgenAmgen
Washington, DC, United States
Biostatistics Manager WHAT YOU WILL DO Lets do this. Lets change the world. In this vital role you will achieve results through detailed goalsetting, accountability measures, effective partnership, performance management, collaborationwith other groups and a dedication to serving customers, both inside and outside of, CfDA (Centerfor Design & Analy
Job Source: AmgenLumen
Washington
**About Lumen** Lumen connects the world. We are igniting business growth by connecting people, data and applications – quickly, securely, and effortlessly. Together, we are building a culture and company from the people up – committed to teamwork, trust and transparency. People power progress. Lumen’s commitment to workplace inclusion and employee
Job Source: LumenAston Carter
Tysons
Residential Junior Buyer | Hybrid- Rockville, MD | 60k - 85k/yr The ideal candidate is energized by a high-growth environment, thrives in structure and ambiguity, enjoys problem-solving, dives into details, and brings exceptional pride of ownership. Responsibilities (includes but is not limited to the following): + Develop and implement effective p
Job Source: Aston CarterRockville
**Position Summary:**
The primary role of this position is to provide statistical support for multiple clinical studies across all phases of clinical development. Apply statistical principles and techniques to a wide range of problems within the clinical development environment with the supervision of more senior staff.
**Responsibilities:**
+ Support biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs, and Business Development
+ Provide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needs
+ Serve as primary author for statistical sections of protocol
+ Create accompanying statistical documents (e.g., statistical analysis plan and mocked shells)
+ Participate in development of EDC database and interactive response technology (IxRS) specifications
+ Collaborate with project management, regulatory, medical affairs, PV/safety, business development, and commercial functions
+ Implement innovative statistical techniques that will provide benefit to clinical development programs
+ Contribute to strategic planning and go/no go decision guidance
+ Review biostatistics and statistical programming tasks outsourced to vendors
+ Perform statistical analyses and create statistical text for clinical publications and other communications, perform SAS programming validation if needed
+ Support the preparation of regulatory submissions documents including summaries of clinical safety and efficacy of BLA/NDAs if needed
+ Ensure timeliness and quality of deliverables
+ Travel as needed to execute assigned responsibilities.
**BASIC** **QUALIFICATIONS**
Doctorate degree and 2 years of experience OR Master’s degree and 6 years of experience OR Bachelor’s degree and 8 years of experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience
**PREFERRED QUALIFICATIUONS**
+ Doctorate degree in biostatistics and at least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research _Or_
+ Master’s degree in biostatistics and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research _._
+ Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
+ Strong verbal and written communication combined with organizational skills and cross-cultural sensitivity
+ Statistical leadership and contribution to regulatory and reimbursement submissions. of regulatory guidelines.
+ Experience working effectively in a globally dispersed team environment with cross-cultural partners.
**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.
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.
**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.
Email Alert for Biostatistics Sr Manager_ jobs in Rockville
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