30 days old

Biostatistical Programming Manager

Amgen
South San Francisco, CA 94080
  • Job Code
    118918459
Amgen

Job ID: R-95718
Location: South San Francisco, CA, US 94083
Additional Location: US - Wyoming - Cheyenne, US - Rhode Island - Providence, US - Texas - Houston, US - Kentucky - Louisville/Jefferson County, US - Georgia - Atlanta, US - Michigan - Detroit, US - Arkansas - Little Rock, US - Kansas - Wichita, US - Mississippi - Jackson, US - Delaware - Wilmington, US - New Mexico - Albuquerque, US - Vermont - Burlington, US - Wisconsin - Milwaukee, US - Pennsylvania - Philadelphia, US - Ohio - Columbus, US - Utah - Salt Lake City, US - New Jersey - Newark, US - Arizona - Phoenix, US - Minnesota - Minneapolis, US - North Dakota - Fargo, US - Iowa - Des Moines, US - Oregon - Portland, US - Connecticut - Bridgeport, US - West Virginia - Charleston, US - Washington D.C., US - Illinois - Chicago, US - Washington - Seattle, US - New Hampshire - Manchester, US - Tennessee - Memphis, US - Oklahoma - Oklahoma City, US - Colorado - Denver, US - California - Los Angeles, US - Nevada - Las Vegas, US - Alabama - Birmingham, US - Indiana - Indianapolis, US - Massachusetts - Boston, US - North Carolina - Charlotte, US - Nebraska - Omaha, US - Florida - Jacksonville, US - Montana - Billings, US - Maryland - Baltimore, US - South Dakota - Sioux Falls, United Kingdom - Uxbridge, US - Idaho - Boise City, US - Maine - Portland, US - Hawaii - Honolulu, US - Louisiana - New Orleans, US - Virginia - Virginia Beach, US - New York - New York, US - Missouri - Kansas City, US - South Carolina - Columbia

The Biostatistical Programming Manager will provide technical expertise and programming leadership to ensure that software tools and utilities are properly developed and maintained to support the analysis and reporting of clinical trial data for GSP. In addition, this individual will guide GSP in developing a future roadmap for data analytics as we incorporate capabilities such as machine learning and AI.

Amgen is building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules. We are seeking top talent to ensure these molecules become medicines and realize their potential for helping patients.

Responsibilities:
  • Develop and maintain departmental software utilities to support the analysis and reporting of clinical trials data
  • Adhere to functional standards, processes and methods across all projects
  • Create, maintain, and review key SDLC documents - Requirements, Operational Qualification, Installation Qualification, and Design documents
  • Create, maintain, and review end-user documentation (e.g., user guides, training materials)
  • Participate in establishing the programming scope, timeline and quality for a deliverable with stakeholders
  • Participate in the selection of appropriate technologies and software development tools
  • Designated team leader responsible for project efficiency, timeliness and quality
  • Manage resource according to priorities. Match programmer abilities to tasks. Efficiently and effectively monitor and utilize assigned staff
  • Provide technical leadership and guidance for programming team
  • Lead all programming-related activities on one or multiple concurrent projects


Basic Qualifications:

Doctorate degree
OR
Master's degree and 3 years Statistical Programming experience
OR
Bachelor's degree and 5 years Statistical Programming experience

OR

Associate's degree and 10 years Statistical Programming experience

OR

High school diploma and 12 years Statistical Programming experience

Preferred Qualifications:

MSc degree in quantitative, software engineering, or scientific subjects

Familiarity with drug development life cycle and experience in analysis of clinical trials data

Working knowledge of latest CDISC SDTM, ADaM and Define-XML standards

Experience implementing test driven design strategies

In-depth knowledge of SAS Graph and Stat packages

In-depth knowledge of programming languages - R and/or Python

Experience working with Oracle databases, including PL/SQL

Ability to train others

Prior leadership and/or management experience

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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.

Get a fair share in success. Everyone's contribution is recognized - and strong performance is rewarded.

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.

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.

PI118918459

<b>Amgen</b><br/><br/><b>Job ID: </b>R-95718<br/><b>Location: </b>South San Francisco, CA, US 94083<br/><b>Additional Location: </b>US - Wyoming - Cheyenne, US - Rhode Island - Providence, US - Texas - Houston, US - Kentucky - Louisville/Jefferson County, US - Georgia - Atlanta, US - Michigan - Detroit, US - Arkansas - Little Rock, US - Kansas - Wichita, US - Mississippi - Jackson, US - Delaware - Wilmington, US - New Mexico - Albuquerque, US - Vermont - Burlington, US - Wisconsin - Milwaukee, US - Pennsylvania - Philadelphia, US - Ohio - Columbus, US - Utah - Salt Lake City, US - New Jersey - Newark, US - Arizona - Phoenix, US - Minnesota - Minneapolis, US - North Dakota - Fargo, US - Iowa - Des Moines, US - Oregon - Portland, US - Connecticut - Bridgeport, US - West Virginia - Charleston, US - Washington D.C., US - Illinois - Chicago, US - Washington - Seattle, US - New Hampshire - Manchester, US - Tennessee - Memphis, US - Oklahoma - Oklahoma City, US - Colorado - Denver, US - California - Los Angeles, US - Nevada - Las Vegas, US - Alabama - Birmingham, US - Indiana - Indianapolis, US - Massachusetts - Boston, US - North Carolina - Charlotte, US - Nebraska - Omaha, US - Florida - Jacksonville, US - Montana - Billings, US - Maryland - Baltimore, US - South Dakota - Sioux Falls, United Kingdom - Uxbridge, US - Idaho - Boise City, US - Maine - Portland, US - Hawaii - Honolulu, US - Louisiana - New Orleans, US - Virginia - Virginia Beach, US - New York - New York, US - Missouri - Kansas City, US - South Carolina - Columbia<br/><br/>The Biostatistical Programming Manager will provide technical expertise and programming leadership to ensure that software tools and utilities are properly developed and maintained to support the analysis and reporting of clinical trial data for GSP. In addition, this individual will guide GSP in developing a future roadmap for data analytics as we incorporate capabilities such as machine learning and AI. <br><br>Amgen is building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules. We are seeking top talent to ensure these molecules become medicines and realize their potential for helping patients. <br><br>Responsibilities: <br><ul><li>Develop and maintain departmental software utilities to support the analysis and reporting of clinical trials data</li><li>Adhere to functional standards, processes and methods across all projects</li><li>Create, maintain, and review key SDLC documents - Requirements, Operational Qualification, Installation Qualification, and Design documents</li><li>Create, maintain, and review end-user documentation (e.g., user guides, training materials)</li><li>Participate in establishing the programming scope, timeline and quality for a deliverable with stakeholders</li><li>Participate in the selection of appropriate technologies and software development tools</li><li>Designated team leader responsible for project efficiency, timeliness and quality</li><li>Manage resource according to priorities. Match programmer abilities to tasks. Efficiently and effectively monitor and utilize assigned staff</li><li>Provide technical leadership and guidance for programming team</li><li>Lead all programming-related activities on one or multiple concurrent projects</li></ul><br><br>Basic Qualifications: <br><br>Doctorate degree <br>OR<br>Master's degree and 3 years Statistical Programming experience<br>OR<br>Bachelor's degree and 5 years Statistical Programming experience<br><br>OR<br><br>Associate's degree and 10 years Statistical Programming experience<br><br>OR<br><br>High school diploma and 12 years Statistical Programming experience<br><br>Preferred Qualifications: <br><br>MSc degree in quantitative, software engineering, or scientific subjects<br><br>Familiarity with drug development life cycle and experience in analysis of clinical trials data<br><br>Working knowledge of latest CDISC SDTM, ADaM and Define-XML standards<br><br>Experience implementing test driven design strategies<br><br>In-depth knowledge of SAS Graph and Stat packages<br><br>In-depth knowledge of programming languages - R and/or Python<br><br>Experience working with Oracle databases, including PL/SQL<br><br>Ability to train others<br><br>Prior leadership and/or management experience<br><br>Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.<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.<br><br>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>Get a fair share in success. Everyone's contribution is recognized - and strong performance is rewarded.<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> Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.<br/><br/> <img src="https://analytics.click2apply.net/v/2Vr1KYfWyjAmUZVPFDBKj"> <p>PI118918459</p>

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Posted: 2020-03-11 Expires: 2020-04-11

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Biostatistical Programming Manager

Amgen
South San Francisco, CA 94080

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