Amgen
Biotechnology
BiostatisticsSrAssociate
Neural analysis suggests this role is
optimal for Senior candidates.
“Biostatistics Sr Associate at Amgen. Skills: Biostatistics, Statistical programming, Clinical trial data. Apply biostatistical methods. Analyze clinical trial data”
What You'll Achieve.
Timely delivery of study outputs
Industry & Context.
Scientific rigor
What They're Looking For.
Must Have
4 years post-graduate experience as a statistician, 2 year post-graduate experience, Competency in statistical programming (R/Python), Experience with R Shiny, Experience applying statistical methods, Ability to clearly communicate in English
Nice to Have
6 + years post-graduate experience, 4 + years post-graduate experience, Prior leadership of at least 1 study/project, Experience authoring protocols, Experience authoring SAPs, Reviewing CSRs, Familiarity with CDISC standards, Experience with AI/automation tools, understanding of drug development, statistical applications across the clinical lifecycle
What You'll Do.
Apply biostatistical methods
Analyze clinical trial data
Interpret clinical trial data
Develop statistical programming solutions
Maintain statistical programming solutions
Collaborate with cross-functional teams
Ensure timely delivery of study outputs
Support study teams with regulatory submission deliverables
Stay abreast of new methodologies
Stay abreast of new tools
Stay abreast of regulatory guidelines
Build automated workflows
Build reproducible reporting pipelines
Contribute to process improvements
Contribute to innovative technologies
Ensure compliance with regulatory requirements
Ensure compliance with internal quality standards
Assist in reviewing Amgen policies
Assist in reviewing SOPs
Assist in reviewing controlled documents
How You'll Work.
Team & Collaboration
Cross-functional teams
Communication Scope
Written communication; Oral communication
Full Job Description
## **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 tech
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