Job Title: Senior Associate – Biostatistics (Study Statistician)
Job ID: R-233541
Location: Hyderabad, India
Department: Clinical / Biostatistics
Employment Type: Full-time, On-site
Posted Date: January 13, 2026
Amgen is a global biotechnology leader dedicated to serving patients by developing innovative therapies that improve and extend lives. With a presence in over 100 countries and products reaching more than 10 million patients worldwide, Amgen fosters a culture of collaboration, scientific rigor, and patient-centric innovation. Join Amgen for a career where your contributions directly impact patient outcomes.
As a Senior Associate in Biostatistics, you will provide statistical expertise across the drug development lifecycle, supporting clinical trials with high-quality analyses, documentation, and cross-functional collaboration. This role offers opportunities to build depth in clinical trial methodology, statistical programming, and collaborative team leadership while contributing to regulatory submissions and scientific publications.
Author and review statistical documents, including Statistical Analysis Plans (SAPs), Table/Figure/Listing (TFL) shells, randomization specifications, and submission data file specifications (SDTM/ADaM).
Conduct, document, and quality-check statistical analyses for primary, secondary, and exploratory endpoints across clinical trials.
Collaborate with Clinical Study Teams (CSTs) and programming colleagues to ensure timely and accurate study deliverables.
Contribute to clinical study reports (CSRs), regulatory submissions, and scientific publications.
Review deliverables from external suppliers for quality and compliance.
Stay updated on new statistical methodologies, tools, and regulatory guidelines.
Maintain statistical sections of the Trial Master File (TMF) and adhere to Amgen SOPs and compliance standards.
Required:
Master’s degree in Statistics, Biostatistics, or a related field with strong statistical content, plus 2 years of post-graduate experience in the pharmaceutical or medical research industry, OR
Doctoral degree in Statistics/Biostatistics or related field with 1 year of post-graduate experience.
Competency in statistical programming (SAS or R).
Experience applying statistical methods in clinical trial design and analysis.
Strong English communication skills, both written and oral.
Preferred:
Master’s degree with 4+ years of experience, or PhD with 2+ years.
Leadership experience in at least one study/project with minimal oversight.
Experience authoring protocols, SAPs, and reviewing CSRs.
Familiarity with CDISC standards (SDTM, ADaM).
Experience leveraging AI or automation tools for statistical analysis.
Deep understanding of drug development and statistical applications across the clinical lifecycle.
Opportunity to work in a global, innovative biotechnology organization.
Exposure to a broad range of statistical deliverables across clinical trials and drug development.
Diverse and inclusive workplace fostering collaboration, learning, and growth.
Competitive benefits including health, financial, career development, and work-life balance support.
Gujarat :
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