Amgen

Biotechnology

BiostatisticsSrAssociate

₹22–35L ~AI est. India FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“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.

Biotechnology
Problems you'll solve

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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