Sr Associate Biostatistics
Amgen · Hyderabad, India
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Role summary
Amgen seeks a Senior Associate in Biostatistics for its clinical development team in Hyderabad. The role involves providing statistical expertise to clinical trials across the drug development lifecycle, authoring statistical documents, performing data analyses, and ensuring regulatory compliance and scientific rigor.
What they're looking for
- Master's degree in Statistics/Biostatistics with 2+ years pharmaceutical industry experience, or Doctorate with 1+ year experience
- Competency in statistical programming using SAS or R
- Experience applying statistical methods to clinical trial analysis and conduct
- Clear written and oral English communication abilities
- Familiarity with CDISC standards (SDTM, ADaM) preferred
- Leadership of at least one study or project with minimal oversight preferred
What you'll be doing
- Author and contribute statistical expertise to Statistical Analysis Plans, randomization specifications, and data file specifications
- Conduct and document statistical analyses for clinical trials including primary, secondary, and exploratory endpoint analyses
- Perform quality control of datasets and outputs to ensure CDISC compliance and accuracy
- Participate in Clinical Study Team meetings to provide statistical input and representation
- Collaborate with programming teams and external suppliers to ensure timely delivery and quality of study outputs
Privacy & handoff
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