Career Category
ClinicalJob Description
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Biostatistical Programming Manager
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate.
The Technical Manager will ensure that projects outsourced to our Functional Service Providers (FSPs) are aligned with our priorities and meet Amgen timeline, quality, data standards and compliance expectations. The Technical Manager will also provide technical consultancy to our FSPs on Amgen processes, tools and utilities.
Responsibilities:
Oversee the execution and quality of projects managed by our FSPs per Amgen Global Statistical Programming (GSP) Quality Oversight Plan (QOP)
Align FSP assignments with Amgen Development priorities
Ensure that FSP programming meets quality, compliance, timeline, and productivity expectations
Contribute to FSP training material development and revisions, and conducting the initial training to FSP staff
Provide guidance and technical consultancy to FSP Study Lead Programmers (SLP) on Amgen processes, tools, and utilities
Contribute to FSP performance metrics development, data collection, and reporting
Review project documentations such as specifications, issue logs, deliverable status for accuracy and completeness
Advise FSP SLP on study-specific questions for specifications, documentation, and coding
Lead/contribute to 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 professional we seek is proficient with these 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 other 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 biopharmaceutical industry
Thorough understanding of clinical trial processes 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 questions
Experience working in a globally dispersed team on Phase 1-4 clinical trials
Excellent oral and written English communication skills; strong negotiation skills
Advanced SAS analysis and reporting skills including SAS Base, macro, and SQL
Hands-on experience in specifying and implementing SDTM and ADaM data sets and TFLs
Thrive
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.
We are all deeply committed to our mission: to serve patients. And we all have opportunities to contribute to that mission in meaningful ways. This creates a powerful sense of shared purpose.
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Equal Opportunity Statement
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 a 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 an accommodation.
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