Career Category

Clinical Development

Job Description

Job 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

5 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

WHAT YOU CAN EXPECT OF US

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.

• Vast opportunities to learn and move up and across our global organization
• 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

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