8 days old

Biostatistics Mgr

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115164553
Amgen

Job ID: R-87218
Location: Thousand Oaks, CA, US 91360

The Biostatistics Mgr will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically correct

Influencing study design, and defending statistical approaches internally and externally

Being the study lead statistician for one complex or multiple less complex studies/projects

Adhering to all Amgen Policies, SOPs and other controlled documents

Key activities include:

Providing statistical contributions and statistical review Key Design Elements (KDE) documents, protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, Data Elements Planning Tool (DEPT), Case Report Forms (CRFs),other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications

Attending cross-functional team meetings and providing statistical input

Overseeing statistical analysis of individual studies/projects

Being familiar with statistical policy and strategy at Amgen

Staying abreast of latest developments in the field of statistics in drug development (eg, innovative study design)

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 and 1 year of statistical experience

Master's degree in Statistics/Biostatistics or other subject with high statistical content and 3 years of statistics experience

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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.

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.

PI115164553

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87218<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Biostatistics Mgr will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically correct<br><br>Influencing study design, and defending statistical approaches internally and externally<br><br>Being the study lead statistician for one complex or multiple less complex studies/projects<br><br>Adhering to all Amgen Policies, SOPs and other controlled documents<br><br>Key activities include:<br><br>Providing statistical contributions and statistical review Key Design Elements (KDE) documents, protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, Data Elements Planning Tool (DEPT), Case Report Forms (CRFs),other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications<br><br>Attending cross-functional team meetings and providing statistical input<br><br>Overseeing statistical analysis of individual studies/projects <br><br>Being familiar with statistical policy and strategy at Amgen<br><br>Staying abreast of latest developments in the field of statistics in drug development (eg, innovative study design)<br><br><b> Basic Qualifications: </b><br><br> Doctoral degree in Statistics/Biostatistics or other subject with high statistical content <br><br> OR <br><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><br> OR <br><br> Master's degree in Statistics/Biostatistics or other subject with high statistical content and 3 years of statistics experience <br><br><b> Preferred Qualifications: </b><br><br>Doctorate degree in statistics or biostatistics and 1 year of statistical experience<br><br>Master's degree in Statistics/Biostatistics or other subject with high statistical content and 3 years of statistics experience<br><br>Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.<br><br>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.<br><br><b> 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. </b><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/7eReRnuYnbPmtZ1NF7Y5y"> <p>PI115164553</p>

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Posted: 2019-11-05 Expires: 2019-12-06

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Biostatistics Mgr

Amgen
Thousand Oaks, CA 91360

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