Biostatistical Programming Senior Associate — Structured Job Format
Job Details
Job Title: Biostatistical Programming Senior Associate
Company: Amgen
Job ID: R-243272
Category: Research
Location: Hyderabad, India
Work Mode: On-site
Date Posted: May 4, 2026
Company Overview
Amgen is a global biotechnology company focused on developing innovative therapies that improve patient outcomes worldwide. The organization supports a collaborative and inclusive work culture driven by scientific innovation and patient impact.
Job Overview
Amgen is expanding its global Statistical Programming capabilities, with the Hyderabad office playing a key role in integrated global delivery.
The Biostatistical Programming Senior Associate will:
Perform hands-on statistical programming activities
Support clinical trial data analysis and regulatory submissions
Work collaboratively with global cross-functional teams
Contribute to SDTM, ADaM, TFL creation and validation
Support study lead programming activities
Key Responsibilities
Statistical Programming
Perform analysis and reporting of clinical trial data using:
SAS
R
Create and validate:
SDTM datasets
ADaM datasets
Analysis datasets
Develop and validate:
Tables
Listings
Figures (TFLs)
Documentation & Regulatory Support
Prepare statistical programming specifications
Prepare programming-related documentation for regulatory submissions
Maintain:
Tracking documentation
Validation documentation
Data Quality & Compliance
Create and validate programs for:
Data quality checks
Compliance checks
Work with data quality and compliance tools
Cross-Functional Collaboration
Collaborate with global study teams and cross-functional stakeholders
Support multiple therapeutic areas and projects
Assist Study Lead Programmer (SLP) activities
Serve as backup SLP when required
Required Qualifications
Education
Bachelor’s degree (BA/BSc) or higher in:
Biostatistics
Statistics
Mathematics
Computer Science
Related quantitative/scientific field
Experience
Minimum 4 years of statistical programming experience in:
Clinical development
Clinical trial environments
Required Skills
Clinical Programming Expertise
Strong knowledge of:
Clinical trial data analysis
Drug development lifecycle
Statistical programming workflows
CDISC Standards
Working knowledge of:
CDISC SDTM standards
ADaM standards
Define.xml standards
SAS & Programming Skills
Strong expertise in:
SAS programming
SAS/STAT packages
Ability to handle complex statistical programming tasks
Data Quality & Compliance
Familiarity with:
Data quality tools
Compliance check tools
Professional Skills
Ability to:
Work under tight timelines
Manage multiple projects
Collaborate in global teams
Strong written and verbal English communication skills
Preferred Qualifications
Education
MSc or higher degree in:
Statistics
Biostatistics
Mathematics
Related quantitative/scientific disciplines
Additional Skills
Familiarity with:
R
Python
Automation platforms
Emerging statistical programming technologies
Prior experience with:
Regulatory submissions
Drug approval processes
Work Environment
On-site role based in Hyderabad, India
Global collaborative work environment
Cross-cultural and cross-functional teamwork
Employee Benefits
Career Growth
Opportunities for:
Learning and development
Internal mobility
Global collaboration
Work Culture
Inclusive and diverse workplace
Encouragement of innovation and idea sharing
Rewards & Benefits
Health and wellness benefits
Financial and wealth programs
Work-life balance initiatives
Career development support
Ideal Candidate Profile
The ideal candidate is:
A results-oriented statistical programmer
Skilled in SAS and clinical data standards
Comfortable with global collaboration
Interested in modern programming technologies and automation
Experienced in clinical trial programming and regulatory support
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