Biostatistics Sr Associate

Responsibilities

• Author and provide statistical contributions to Statistical Analysis Plans (SAPs), TFL shells, randomization specifications, and SDTM/ADaM specifications.
• Conduct and document statistical analyses for clinical trials, including primary/secondary endpoint and exploratory analyses.
• Perform quality control (QC) of datasets and outputs to ensure compliance with CDISC standards.
• Participate in Clinical Study Team (CST) meetings to provide statistical input and representation.
• Collaborate with programming teams to ensure timely delivery of study outputs.
• Contribute to clinical publications, study reports, and regulatory submissions.
• Support the review of deliverables from external suppliers and maintain the Trial Master File (TMF).

Requirements

• Bachelor’s degree in Statistics/Biostatistics (or related field) with 5-9 years of experience in pharmaceutical or medical research.
• Master’s degree in Statistics/Biostatistics with 4+ years of post-graduate experience.
• Doctorate in Statistics/Biostatistics with 2+ years of experience.
• Proficiency in statistical programming using SAS or R.
• Proven experience applying statistical methods in the analysis and conduct of clinical trials.
• Fluency in English, both written and oral.

Preferred Qualifications

• Prior leadership of at least one study or project with minimal oversight.
• Experience authoring protocols, SAPs, and reviewing Clinical Study Reports (CSRs).
• Familiarity with CDISC standards (SDTM, ADaM).
• Experience utilizing AI or automation tools to drive efficiency.
• Strong understanding of drug development and statistical applications across the clinical lifecycle.

Benefits

• Vast opportunities to learn and develop within a global organization.
• Diverse and inclusive community of belonging.
• Generous Total Rewards Plan including health, finance, wealth, and work/life balance benefits.

About the Company

Amgen is a leading biotechnology company dedicated to unlocking the potential of biology to serve patients suffering from serious illnesses. By leveraging advanced human genetics and biologics manufacturing expertise, Amgen discovers, develops, and delivers innovative human therapeutics to millions of patients worldwide.