Career Category

Clinical Development

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

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.

Biostatistics Sr Associate

What you will do

Let’s do this. Let’s change the world.

Amgen is expanding its global Biostatistics capabilities, with Amgen India playing a key role in integrated delivery and functional leadership. As a Biostatistics Senior Associate, you will provide hands-on statistical expertise to clinical studies across the drug development lifecycle. You will author and review statistical documents, perform data analyses, and collaborate cross-functionally to ensure scientific rigor, regulatory compliance, and timely delivery of study outputs.

This role provides an opportunity to gain breadth across statistical deliverables while developing depth in clinical trial methodology, programming, and cross-functional teamwork.

Responsibilities:

• Apply biostatistical methods to analyze and interpret clinical trial data
• Develop and maintain statistical programming solutions using R for data analysis, reporting, and automation
• Collaborate with cross-functional teams to ensure timely delivery of study outputs
• Support study teams with regulatory submission deliverables following industry standards such as CDISC (SDTM, ADaM) where applicable
• Stay abreast of new methodologies, tools, and regulatory guidelines in statistical practice
• Build automated workflows and reproducible reporting pipelines to improve efficiency and quality of statistical outputs
• Contribute to process improvements and innovative technologies that optimize statistical programming and reporting workflows
• Ensure compliance with regulatory requirements and internal quality standards
• Assist in reviewing Amgen policies, SOPs, and controlled documents to ensure compliance

This position is currently located at Amgen India (Hyderabad).

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 a strategic Biostatistics leader with a passion for tech-enabled transformation.

Basic Qualifications:

• Master’s degree in Statistics/Biostatistics (or related subject with high statistical content) with 4 years post-graduate experience as a statistician in the pharmaceutical industry or medical research, OR
• Doctoral degree in Statistics/Biostatistics (or related subject with high statistical content) with 2 year post-graduate experience.
• Competency in statistical programming (R/Python).
• Experience with R Shiny or interactive reporting tools
• Experience applying statistical methods in the analysis and conduct of clinical trials.
• Ability to clearly communicate in English, both written and oral.

Preferred Skills:

• Master’s degree with 6+ years post-graduate experience, or Doctorate with 4+ years.
• Prior leadership of at least 1 study/project with minimal oversight.
• Experience authoring protocols, SAPs, and reviewing CSRs.
• Familiarity with CDISC standards (SDTM, ADaM).
• Experience with AI/automation tools to drive efficiency.
• Strong understanding of drug development and statistical applications across the clinical lifecycle.

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 develop within 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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