Career Category

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

In this vital role you will be responsible 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 implementation 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 onboarding training material development and revisions, and support the initial training of FSP staff
• Contribute to FSP performance metrics development, data collection and reporting

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The experienced biostatistical programming professional we seek is a leader with these qualifications.

Basic Qualifications

• Doctorate degree in Statistics, Mathematics, Public Health (Epidemiology), Computer Science, Life Sciences (pharmacy, medical or biological, biochemistry, or biotech)  other relevant scientific subject (include but not limited to: physics, chemistry, other sciences or engineering) OR
• Master’s degree and 3 years of in Statistics, Mathematics, Public Health (Epidemiology), Computer Science, Life Sciences (pharmacy, medical or biological, biochemistry, or biotech)  other relevant scientific subject (include but not limited to: physics, chemistry, other sciences or engineering) OR
• Bachelor’s degree and 5 years of  in in Statistics, Mathematics, Public Health (Epidemiology), Computer Science, Life Sciences (pharmacy, medical or biological, biochemistry, or biotech)  other relevant scientific subject (include but not limited to: physics, chemistry, other sciences or engineering)    OR

Preferred Qualifications:

• MS in Statistics, Mathematics, Public Health (Epidemiology), Computer Science, Life Sciences (pharmacy, medical or biological, biochemistry, or biotech)  other relevant scientific subject (include but not limited to: physics, chemistry, other sciences or engineering)
• At lease 6 years of statistical programming experience in a biopharmaceutical industry
• Thorough understanding of clinical trial processes in the biopharmaceutical industry, from data collection to analysis reporting and regulatory submissions
• 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 trial;
• Excellent oral and written English communication skills; strong negotiation skills
• Advanced SAS analytics and reporting skills including SAS Base, STAT, macro, and SQL
• Hands on experience in specifying and implementing SDTM and ADaM data sets and Tables, Figures, and Listings
• 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 such as Pinnacle 21

Knowledge

• Thought leadership
• Ability to define and implement an effective standardization strategy for the product following the latest CDISC SDTM, ADaM and define standards
• General therapeutic area knowledge

Thrive

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.

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