Join Amgen as a Biostatistical Programming Manager
Career Category: Clinical
About Amgen
At Amgen, we defy imagination to achieve remarkable results. Our mission to serve patients drives everything we do, making us one of the world’s leading biotechnology companies, reaching over 10 million patients globally. Use your hard-earned degree to become the professional you're meant to be in this meaningful role.
Job Description
Biostatistical Programming Manager
We are looking for a Biostatistical Programming Manager to join our team. In this role, you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate. You will manage outsourcing projects to ensure alignment with Amgen’s priorities, plus provide technical consultancy to our Functional Service Providers (FSPs).
Responsibilities
- Oversee the execution and quality of projects managed by FSPs per Amgen Global Statistical Programming (GSP) Quality Oversight Plan (QOP)
- Align FSP assignments with Amgen Development priorities
- Ensure FSP programming meets quality, compliance, timeline, and productivity expectations
- Contribute to FSP training material development and revisions
- Provide guidance and technical consultancy to FSP Study Lead Programmers (SLP)
- Contribute to FSP performance metrics development, data collection, and reporting
- Review project documentation for accuracy and completeness
- Lead and contribute to GSP continuous improvement initiatives
Qualifications
Basic Qualifications
- Doctorate degree, OR
- Master’s degree and 2 years of statistical programming experience, OR
- Bachelor’s degree and 4 years of statistical programming experience, OR
- Associate’s degree and 8 years of statistical programming experience, OR
- High school diploma / GED and 10 years of statistical programming experience
Preferred Qualifications
- MSc in Computer Science, Statistics, Mathematics, Life Sciences, or another relevant scientific subject
- Regulatory submission experience
- Vendor and resource management experience
- Familiarity with programming languages such as R or Python
- In-depth knowledge of SAS/Graph and Stat packages
- Thorough understanding of data compliance checks such as Pinnacle 21
- 6+ years of statistical programming in the biopharmaceutical industry
- Thorough understanding of clinical trial processes from data collection to analysis reporting
- Ability to lead programmers and guide technical and process questions
- Experience working on Phase 1-4 clinical trials in a global team
- Excellent oral and written English communication and strong negotiation skills
- Advanced SAS analysis and reporting skills, including SAS Base, macro, and SQL
- Hands-on experience with SDTM and ADaM datasets and TFLs
Why Amgen?
Amgen offers a unique culture driven by a powerful shared purpose—serving patients. We foster a diverse and inclusive community where everyone is empowered to contribute and grow professionally and personally.
Our Total Rewards Plan includes:
- Full support and career-development resources
- A diverse and inclusive community of belonging
- Generous compensation and benefits package
Apply Now
Don't miss out on this incredible opportunity to contribute to life-changing biotechnology advancements. Join us at .
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and considers all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We provide reasonable accommodation to ensure individuals with disabilities can participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
Salary Range: