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 ManagerLive
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
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:
Masters degree and 3 years of Statistics/Biostatistics, Mathematics, Computer Science, Life Sciences or other relevant scientific subject
Bachelors degree and 5 years of Statistics/Biostatistics, Mathematics, Computer Science, Life Sciences or other relevant scientific subject
Associates degree and 10 years of Statistics/Biostatistics, Mathematics, Computer Science, Life Sciences or other relevant scientific subject
High school diploma / GED and 12 years of Statistics/Biostatistics, Mathematics, Computer Science, Life Sciences or other relevant scientific subjectPreferred 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
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
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.