18 days old

Biostatistics Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117847174
Amgen

Job ID: R-92478
Location: Thousand Oaks, CA, US 91360

The Biostatistics Manager 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. Key activities include:
  • Providing 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.
  • Completing statistical analysis of individual studies/projects.
  • Publishing 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.
  • Keeping full knowledge of Amgen's statistical policies and strategies.
  • Staying abreast of the latest developments in the field of statistics in drug development and contributing to scientific advances in the field.
  • Communicating the role of the Global Biostatistics department within the company and contributing to statistical training.
  • Assisting in the reviews of Amgen Policies, SOPs, controlled documents and study and systems audits conducted by Amgen CQA and external bodies.
  • Serving as team member of change / process improvement initiatives.


Basic Qualifications:

Doctoral degree in Statistics/Biostatistics or other subject with high statistical content
OR
Currently enrolled in PhD program in Statistics/Biostatistics or other subject matter with high statistical content, and must complete all requirements necessary to obtain Doctoral Degree in the PhD program prior to employment start date
OR
Master's degree in Statistics/Biostatistics or other subject with high statistical content
AND
3 years of statistics experience

Preferred Qualifications:

Doctorate degree in Statistics or Biostatistics.

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.

PI117847174

<b>Amgen</b><br/><br/><b>Job ID: </b>R-92478<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Biostatistics Manager 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. Key activities include:<br><ul><li>Providing 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.</li><li>Completing statistical analysis of individual studies/projects. </li><li>Publishing 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.</li><li>Keeping full knowledge of Amgen's statistical policies and strategies.</li><li>Staying abreast of the latest developments in the field of statistics in drug development and contributing to scientific advances in the field.</li><li>Communicating the role of the Global Biostatistics department within the company and contributing to statistical training.</li><li>Assisting in the reviews of Amgen Policies, SOPs, controlled documents and study and systems audits conducted by Amgen CQA and external bodies.</li><li>Serving as team member of change / process improvement initiatives.</li></ul><br><br>Basic Qualifications: <br><br>Doctoral degree in Statistics/Biostatistics or other subject with high statistical content<br>OR<br>Currently enrolled in PhD program in Statistics/Biostatistics or other subject matter with high statistical content, and must complete all requirements necessary to obtain Doctoral Degree in the PhD program prior to employment start date<br>OR<br>Master's degree in Statistics/Biostatistics or other subject with high statistical content<br>AND<br>3 years of statistics experience<br><br>Preferred Qualifications: <br><br>Doctorate degree in Statistics or Biostatistics.<br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/5DOL4xhjxxaBH8O6CpWBQ"> <p>PI117847174</p>

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Posted: 2020-02-06 Expires: 2020-03-08

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Biostatistics Manager

Amgen
Thousand Oaks, CA 91360

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