12 days old

Biostatistical Programming Sr. Manager (Product Lead Programmer)

Amgen
Thousand Oaks, CA 91360
  • Job Code
    116922974
  • Jobs Rated
    61st
Amgen

Job ID: R-89893
Location: Thousand Oaks, CA, US 91360

Amgen Global Statistical Programming Department (GSP) is seeking a Biostatistical Programming Senior Manager (Product Lead Programmer) to lead a group of products. This Senior Manager will be accountable and responsible for GSP study deliverables and submission activities for the assigned product areas.

Responsibilities:
  • Accountable and responsible for the Global Statistical Programming (GSP) study deliverables and submission activities for a group of Amgen products
  • Set and drive forward the programming strategies such as functional standards and industry requirements for the assigned product areas globally
  • Plan and monitor progress of projects and address issues accordingly
  • Support GSP Functional Service Provider (FSP) model and provide oversight for assigned products
  • Provide GSP product level input to developing and managing resource plans and budgets for GSP
  • Lead and/or participate in departmental process improvement initiatives and cross-functional working groups
  • Assist in study and system audits by internal and external bodies
  • Develop, review and implement Policies, SOPs and other controlled documents affecting GSP globally
  • Provide hands-on support to the assigned product areas as required
  • Provide coaching and mentoring to staff
  • Provide input into career development plans for all staff on assigned projects

Basic Qualifications:

Doctorate degree and 2 years Statistical Programming in Pharmaceutical Industry experience
OR
Master's degree and 6 years Statistical Programming in Pharmaceutical Industry experience
OR
Bachelor's degree and 8 years Statistical Programming in Pharmaceutical Industry experience

Preferred Qualifications:
  • Experience following a formal software development lifecycle
  • Ability to train others
  • Familiar with other programming languages (e.g. Java, R, or S-Plus)
  • In depth knowledge of SAS Graph, SAS STAT, SAS Macro and SQL
  • Prior regulatory submission experience
  • Thorough understanding and experience with data quality and compliance checks (e.g. P21E)
  • 8+ years of relevant statistical programming experience in a clinical development environment
  • Experience working effectively in a globally dispersed team environment with cross-cultural partners
  • Excellent oral and written communication skills
  • Good negotiation skills
  • Prior staff development leadership and project management experience
  • Advanced SAS analysis and reporting skills
  • Ability to lead and manage programmers in the successful and timely completion of all programming activities for a study or multiple studies from end to end
  • Ability to effectively perform complex statistical programming and related tasks
  • Experience working on studies of all phases


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.

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.

PI116922974

<b>Amgen</b><br/><br/><b>Job ID: </b>R-89893<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen Global Statistical Programming Department (GSP) is seeking a Biostatistical Programming Senior Manager (Product Lead Programmer) to lead a group of products. This Senior Manager will be accountable and responsible for GSP study deliverables and submission activities for the assigned product areas.<br><br>Responsibilities: <br><ul><li>Accountable and responsible for the Global Statistical Programming (GSP) study deliverables and submission activities for a group of Amgen products</li><li>Set and drive forward the programming strategies such as functional standards and industry requirements for the assigned product areas globally</li><li>Plan and monitor progress of projects and address issues accordingly</li><li>Support GSP Functional Service Provider (FSP) model and provide oversight for assigned products</li><li>Provide GSP product level input to developing and managing resource plans and budgets for GSP</li><li>Lead and/or participate in departmental process improvement initiatives and cross-functional working groups</li><li>Assist in study and system audits by internal and external bodies</li><li>Develop, review and implement Policies, SOPs and other controlled documents affecting GSP globally</li><li>Provide hands-on support to the assigned product areas as required</li><li>Provide coaching and mentoring to staff</li><li>Provide input into career development plans for all staff on assigned projects</li><li></li></ul><br> Basic Qualifications: <br><br>Doctorate degree and 2 years Statistical Programming in Pharmaceutical Industry experience<br>OR<br>Master's degree and 6 years Statistical Programming in Pharmaceutical Industry experience<br>OR<br>Bachelor's degree and 8 years Statistical Programming in Pharmaceutical Industry experience<br><br>Preferred Qualifications: <br><ul><li>Experience following a formal software development lifecycle</li><li>Ability to train others</li></ul><ul><li>Familiar with other programming languages (e.g. Java, R, or S-Plus)</li><li>In depth knowledge of SAS Graph, SAS STAT, SAS Macro and SQL</li><li>Prior regulatory submission experience</li><li>Thorough understanding and experience with data quality and compliance checks (e.g. P21E)</li><li>8+ years of relevant statistical programming experience in a clinical development environment</li><li>Experience working effectively in a globally dispersed team environment with cross-cultural partners</li><li>Excellent oral and written communication skills</li><li>Good negotiation skills</li><li>Prior staff development leadership and project management experience</li><li>Advanced SAS analysis and reporting skills</li><li>Ability to lead and manage programmers in the successful and timely completion of all programming activities for a study or multiple studies from end to end</li><li>Ability to effectively perform complex statistical programming and related tasks</li><li>Experience working on studies of all phases</li></ul><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>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/6ePaAOUgx1GRF8lwCoqNG"> <p>PI116922974</p>

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Posted: 2020-01-08 Expires: 2020-02-08

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Biostatistical Programming Sr. Manager (Product Lead Programmer)

Amgen
Thousand Oaks, CA 91360

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