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Biostatistical Programming Manager Technical Manager

Employer
Amgen
Location
Washington D.C., District of Columbia
Start date
Nov 28, 2023

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Biostatistical Programming Manager Technical Manager

Live

What you will do

Lets do this. Lets change the world. In this vital role you will be oversee our Functional Services Provider (FSP) focusing on operational excellence and delivering projects on time to the levels of high quality and compliance. You will coordinate the execution and quality of projects managed by FSP and ensure that projects are prioritized according to the product strategy.

  • Responsible for projects managed by our FSP partners per Amgen Global Statistical Programming (GSP) Quality Oversight Plan (QOP)
  • Ensure that FSP programming meets quality, compliance, timeline, and productivity expectations
  • Align FSP assignments with Amgen Development priorities
  • Responsible for FSP performance metrics development, data collection, and reporting and lead the GSP continuous improvement initiatives
Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a strong collaborator with these qualifications.

Basic Qualifications:Doctorate degree

OR

Masters degree and 3 years of Statistics/Biostatistics, Mathematics, Computer Science, Life Sciences or other relevant scientific subject

Or

Bachelors degree and 5 years of Statistics/Biostatistics, Mathematics, Computer Science, Life Sciences or other relevant scientific subject

Or

Associates degree and 10 years of Statistics/Biostatistics, Mathematics, Computer Science, Life Sciences or other relevant scientific subject

Or

High school diploma / GED and 12 years of Statistics/Biostatistics, Mathematics, Computer Science, Life Sciences or other relevant scientific subject

Preferred Qualifications:
  • Masters Degree in Statistics/Biostatistics, Mathematics, Computer Science, Life Sciences or other relevant scientific subject with least 6 years of statistical programming experience in biopharmaceutical industry
  • Extensive SAS programming and reporting experience including SAS Base, Macro, STAT, Graph, and SQL, among others
  • Detailed understanding of clinical trial processes in the biopharmaceutical industry, from data collection to analysis reporting
  • Ability to lead programmers in successful completion of all study programming activities and provide guidance on technical and process related questions
  • Experience working in a globally dispersed team on Phase 1-4 clinical trials
  • Experience creating SDTM and ADaM data sets, Tables, Figures and Listings
  • Ability to define and implement an effective standardization strategy for a product following the latest CDISC SDTM, ADaM and define standards.
  • Familiarity with other programming languages such as R and Python
  • In-depth knowledge of SAS/Graph and STAT
  • Regulatory submission experience andVendor and resource management experience
  • Detailed understanding of data compliance checks such as Pinnacle 21
Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible
Apply now

for a career that defies imagination

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

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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