Career Category

Job Description

If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

BIOSTATISTICAL PROGRAMMING MANAGER – TECHNICAL MANAGER

LIVE

WHAT YOU WILL DO

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

• Ensure FSP programming meets quality, compliance, timeliness, and productivity expectations
• Ensure FSP adheres to relevant Amgen Policies, SOPs and other controlled documents as per Statement of Work
• Align FSP assignments with Amgen Development priorities
• Provide guidance to FSP Study Lead Programmers (SLP) on Amgen Global Statistical Programming (GSP) processes, tools, and utilities
• Contribute to FSP on-boarding training material development and revisions, and support the initial training of FSP staff
• Contribute to FSP performance metrics data collection and reporting

BE PART OF OUR TEAM

You would be joining the Global Statistical Programming team who serve patients by translating clinical study data into meaningful summaries to support high-quality submissions.

WIN

WHAT WE EXPECT OF YOU

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

• A degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject
• Extensive SAS programming and reporting experience in the Biopharmaceutical industry including SAS Base, macro, and SQL
• A thorough understanding of clinical trial processes in the biopharmaceutical industry, from data collection to analysis reporting
• An 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 in specifying and creating SDTM and ADaM data sets, Tables, Figures and Listings
• An ability to define and implement an effective standardization strategy for a product following the latest CDISC SDTM, ADaM and define standards.

Preferred skills

• Regulatory submission experience
• Vendor and resource management experience
• Thorough understanding of data compliance checks such as Pinnacle 21
• Familiarity with other programming languages such as R or Python

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