Biostatistical Programming Senior Associate | Amgen India
Location: Hyderabad, India (On-site)
Category: Engineering / Clinical Data & Biostatistics
Posted Date: 18 Dec 2025
Job ID: R-232856
Company Overview:
Amgen is a global biotechnology leader dedicated to serving patients by developing innovative therapies that improve lives. With operations spanning worldwide, Amgen collaborates across research, manufacturing, and clinical development to deliver life-changing treatments to over 10 million patients globally. Join Amgen to be part of a team driving scientific innovation, clinical excellence, and digital transformation.
Role Overview:
Amgen India (AIN) is expanding its global Statistical Programming capabilities, supporting integrated delivery across regions. As a Biostatistical Programming Senior Associate, you will perform advanced statistical programming tasks, support clinical trial data analysis, and contribute to regulatory submissions. This role is ideal for professionals with strong SAS/R expertise, deep knowledge of CDISC standards, and experience in global clinical development environments.
Key Responsibilities:
Analyze and report clinical trial data using SAS and/or R.
Create and validate complex SDTM, ADaM, and other analysis datasets for both safety and efficacy.
Develop and validate tables, listings, and figures (TLFs) for clinical study reporting.
Prepare statistical programming specifications and documentation for regulatory submissions.
Maintain tracking and validation documentation for programming activities.
Collaborate with cross-functional global teams to validate complex programs and ensure data quality.
Serve as backup to Study Lead Programmer (SLP) or assist in SLP tasks as required.
Support quality control and compliance in all programming deliverables.
Qualifications and Experience:
BA/BSc or higher degree in Biostatistics, Statistics, Mathematics, Computer Science, or related quantitative/scientific discipline.
Minimum 4 years of statistical programming experience in a clinical development environment.
Strong expertise in SAS/STAT, SDTM, ADaM, and Define-XML standards.
Familiarity with drug development lifecycle, clinical trial operations, and regulatory submission requirements.
Experience with data quality checks, compliance tools, and cross-functional team collaboration.
Excellent written and verbal English communication skills.
Preferred Qualifications:
MSc or higher degree in Biostatistics, Statistics, Mathematics, or related quantitative/scientific discipline.
Familiarity with R, Python, automation platforms, and emerging statistical programming technologies.
Prior experience supporting regulatory submissions for drug approvals.
Experience working in a globally dispersed team environment with cross-cultural partners.
What Amgen Offers:
Opportunities for career growth and global mobility within a leading biotechnology company.
Inclusive, diverse, and collaborative work culture fostering innovation and professional development.
Comprehensive Total Rewards package including health, finance, work-life balance, and career benefits.
A platform to contribute directly to scientific advancements and patient-centered solutions.
Application Note:
Apply now to join Amgen India as a Biostatistical Programming Senior Associate and contribute to cutting-edge clinical development programs that impact patient lives worldwide.
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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