Biostatistics Manager

2 months ago

Washington DC, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Biostatistics Manager - Oncology

Live

What you will do

Lets do this. Lets change the world. In this vital role you will leads projects and studies, ensuring all statistical aspects pertaining to clinical activities meet required standards and are statistically correct while influencing study design, defending statistical approaches and adhering to Amgen Policies, SOPs and other controlled documents.

  • Provide statistical contributions, statistical review and quality control of Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications and other communications.
  • Complete statistical analysis of individual studies/projects.
  • Publish applied research in scientific journals and books, making presentations on statistical methodology in the biopharmaceutical setting at external scientific functions such as biopharmaceutical industry and academic meetings.
  • Keep full knowledge of Amgens statistical policies and strategies.
  • Stay abreast of the latest developments in the field of statistics in drug development and contributing to scientific advances in the field.
  • Communicate the role of the Global Biostatistics department within the company and contributing to statistical training.
  • Assist in the reviews of Amgen Policies, SOPs, controlled documents and study and systems audits conducted by Amgen CQA and external bodies.
  • Serve as team member of change / process improvement initiatives.

    Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go-getter with these qualifications.

    Basic Qualifications:

    • Doctorate degree OR
    • Masters degree and 3 years Statistics/Biostatistics experience OR
    • Bachelors degree and 5 years Statistics/Biostatistics experience OR
    • Associates degree and 10 years Statistics/Biostatistics research experience Or
    • High school diploma / GED and 12 years of Statistics/Biostatistics experience

      Preferred Qualifications:

      • Doctoral degree in Statistics/Biostatistics or other subject with high statistical content

        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 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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