Career Category

Clinical

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.

Biostatistics 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 Biostatistics Mgr. will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically correct

Influencing study design, and defending statistical approaches internally and externally

Leading one complex or multiple fewer complex studies/projects

Adhering to all Amgen Policies, SOPs and other controlled documents.

Key activities include:

Providing statistical contributions, statistical review and quality control of Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study related documentation, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, and other communications

Completing statistical analysis of individual studies/projects

Publishing applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)

Being familiar with statistical policy and strategy at Amgen

Staying abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field

Communicating the role of the Global Biostatistics department, and may contribute to statistical training within Global Biostatistics and within Amgen

Assisting in the review of Amgen Policies, SOPs and other controlled documents

Assisting with study and systems audits conducted by Amgen CQA and external bodies

Serving as team member of change / process 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.

Doctorate degree

OR

Master’s degree and 4 years of Statistics/Biostatistics or other subject with high statistical content experience

Or

Bachelor’s degree and 6 years of Statistics/Biostatistics or other subject with high statistical content experience.

Preferred Qualifications:

Doctorate degree in statistics or biostatistics

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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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.

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.