Amgen
biotechnology
BiostatisticsSrAssociate(StudyStatistician)
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“Biostatistics Sr Associate (Study Statistician) at Amgen. Skills: statistical expertise, statistical programming, clinical trial methodology, statistical analyses. Provide hands-on statistical expertise to clinical studies across the drug development lifecycle.. Author and review statistical documents.”
What You'll Achieve.
timely delivery of study outputs
Industry & Context.
statistical expertise
What They're Looking For.
Must Have
Master's degree in Statistics/Biostatistics (or related subject with high statistical content) with 2 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 1 year post-graduate experience., Competency in statistical programming (SAS or R)., Experience applying statistical methods in the analysis and conduct of clinical trials., Ability to clearly communicate in English, both written and oral.
Nice to Have
Master's degree with 4 + years post-graduate experience, or Doctorate with 2 + 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., Understanding of drug development and statistical applications across the clinical lifecycle.
What You'll Do.
Provide hands-on statistical expertise to clinical studies across the drug development lifecycle.
Author and review statistical documents.
Perform data analyses.
Collaborate cross-functionally to ensure scientific rigor
regulatory compliance
and timely delivery of study outputs.
Author and provide statistical contributions to Statistical Analysis Plans (SAPs)
Table/Figure/Listing (TFL) shells
randomization specifications
submission data file specifications (SDTM/ADaM)
and other key study-related documentation.
Conduct and document statistical analyses for clinical trials
including primary and secondary endpoint analyses
and dose-level review support.
Perform and document quality control (QC) of datasets and outputs to ensure accuracy
and compliance with CDISC standards.
Contribute to clinical publications
and regulatory submissions.
Support the review of deliverables from external suppliers for quality.
Ensure that statistical sections of the Trial Master File (TMF) are maintained and up to date.
How You'll Work.
Team & Collaboration
Collaborate cross-functionally to ensure scientific rigor, regulatory compliance, and timely delivery of study outputs.; Participate in Clinical Study Team (CST) meetings to provide statistical input and represent Biostatistics.; Collaborate with programming colleagues to ensure timely delivery of study outputs.
Communication Scope
Ability to clearly communicate in English, both written and oral.
Process & Methodology
Prior leadership of at least 1 study/project with minimal oversight.
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 (AIN) 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:** * Author and provide statistical contributions to Statistical Analysis Plans (SAPs), Table/Figure/Listing (TFL) shells, randomization specifications, submission data file specifications (SDTM/ADaM), and other key study-related documentation. * Conduct and document statistical analyses for clinical trials, including primary and secondary endpoint analyses, exploratory analyses, and dose-level review support. * Perform and document quality control (QC) of datasets and outputs to ensure accuracy, consistency, and compliance with CDISC standards. * Participate in Clinical Study Team (CST) meetings to provide statistical input and represent Biostatistics. * Collaborate
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