Senior Associate Biostatistics

About the role

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, authoring and reviewing statistical documents, performing data analyses and collaborating cross-functionally. The role offers breadth across statistical deliverables while developing depth in clinical trial methodology, programming and teamwork. The position is based in Hyderabad.

Key responsibilities

• Author statistical contributions to Statistical Analysis Plans (SAPs), TFL shells, randomization specifications, SDTM/ADaM file specifications and other study documentation.
• Conduct and document statistical analyses, including primary and secondary endpoints, exploratory analyses and dose-level review support.
• Perform and document quality control of datasets and outputs in line with CDISC standards.
• Take part in Clinical Study Team meetings and collaborate with programming colleagues on timely delivery of study outputs.
• Contribute to clinical publications, study reports and regulatory submissions, and review external supplier deliverables for quality.
• Keep the statistical sections of the Trial Master File up to date and support audits as needed.

Required profile

• Master's degree in Statistics/Biostatistics (or related subject) with 2 years of post-graduate experience as a statistician in pharma or medical research, or a doctorate with 1 year of post-graduate experience.
• Ability to communicate clearly in English, written and oral.
• Preferred: 4+ years of post-graduate experience with a master's, or 2+ years with a doctorate; prior leadership of at least one study or project; experience authoring protocols and SAPs and reviewing CSRs.

Required skills

• Competence in statistical programming (SAS or R).
• Experience applying statistical methods in clinical trials.
• Familiarity with CDISC standards (SDTM, ADaM) preferred.
• Experience with AI/automation tools and strong understanding of drug development preferred.

What we offer

• Vast opportunities to learn and develop within a global organization.
• A generous total rewards plan covering health, finance and wealth, work/life balance and career benefits.