Biostatistics Manager, Oncology (U.S. - Remote)

Amgen

Charlotte North Carolina

United States

Customer Service / Call Center
(No Timezone Provided)

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, 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

Let’s do this. Let’s 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 Amgen’s 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
  • Master’s degree and 3 years Statistics/Biostatistics experience OR
  • Bachelor’s degree and 5 years Statistics/Biostatistics experience OR
  • Associate’s 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

    Some of the vast rewards of working here

    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.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
  • Apply now

    for a career that defies imagination

    Objects in your future are closer than they appear. Join us.

    careers.amgen.com

    Equal Opportunity Statement

    Biostatistics Manager, Oncology (U.S. - Remote)

    Amgen

    Charlotte North Carolina

    United States

    Customer Service / Call Center

    (No Timezone Provided)

    HOW MIGHT YOU DEFY IMAGINATION?

    You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, 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

    Let’s do this. Let’s 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 Amgen’s 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
  • Master’s degree and 3 years Statistics/Biostatistics experience OR
  • Bachelor’s degree and 5 years Statistics/Biostatistics experience OR
  • Associate’s 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

    Some of the vast rewards of working here

    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.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
  • Apply now

    for a career that defies imagination

    Objects in your future are closer than they appear. Join us.

    careers.amgen.com

    Equal Opportunity Statement