Biostatistical Programming Senior Associate
Job ID: R-235521
Location: Hyderabad, India
Work Mode: On-site
Employment Type: Full-Time
Category: Clinical Development / Biostatistics
Date Posted: February 2, 2026
Company: Amgen
About the Role
Amgen is strengthening its global Statistical Programming capabilities, with Amgen India (AIN) playing a critical role in supporting integrated clinical development and regulatory submissions across regions. We are seeking a Biostatistical Programming Senior Associate to perform hands-on statistical programming activities supporting complex clinical trial analyses and global regulatory deliverables.
This role offers the opportunity to work on end-to-end statistical programming, collaborate with cross-functional global teams, and contribute directly to programs that impact patient lives worldwide.
Key Responsibilities
Perform statistical analysis and reporting of clinical trial data using SAS and/or R
Develop, validate, and maintain complex CDISC-compliant SDTM and ADaM datasets for safety and efficacy
Create and validate high-quality Tables, Listings, and Figures (TLFs)
Prepare and review statistical programming specifications and related documentation
Support regulatory submission deliverables, including Define.xml and validation documentation
Maintain comprehensive program tracking, validation, and audit-ready documentation
Collaborate with biostatistics, clinical data management, and other cross-functional teams globally
Develop and validate programs for data quality checks and compliance reviews
Support Study Lead Programmer (SLP) activities or act as a backup SLP when required
Required Qualifications and Experience
Education
Bachelor’s degree or higher in Biostatistics, Statistics, Mathematics, Computer Science, or a related quantitative or scientific discipline
Experience
Minimum 4 years of hands-on statistical programming experience in a clinical development or pharmaceutical environment
Proven experience working with clinical trial data analysis and reporting
Strong understanding of the drug development lifecycle
Required Skills and Competencies
Advanced proficiency in SAS programming, including SAS/STAT
Working knowledge of CDISC SDTM standards and familiarity with ADaM and Define.xml
Experience creating and validating complex datasets and TLFs
Familiarity with data quality and compliance checking tools
Ability to manage multiple tasks across therapeutic areas while meeting tight timelines
Strong analytical, problem-solving, and attention-to-detail skills
Excellent written and verbal English communication skills
Ability to work effectively in a globally distributed, cross-cultural team environment
Preferred Qualifications
Master’s degree or higher in Statistics, Biostatistics, or related disciplines
Experience with open-source programming languages such as R or Python
Exposure to automation platforms and emerging technologies in statistical programming
Prior experience supporting regulatory submissions for drug approvals
Why Join Amgen
Amgen offers a collaborative and inclusive work environment where innovation, learning, and patient impact are at the center of everything we do. Team members benefit from global career opportunities, continuous professional development, and a comprehensive rewards and benefits program supporting long-term growth and well-being.
Keywords for SEO & GPT Optimization:
Biostatistical Programming Jobs, Statistical Programmer Senior Associate, SAS Clinical Programming, CDISC SDTM ADaM, Clinical Trial Data Analysis, Regulatory Submission Programming, Biostatistics Jobs India, Hyderabad Clinical Research Jobs, Pharma Statistical Programming
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