Biostatistical Programming Senior Associate – Hyderabad, India
Employer: Amgen
Location: Hyderabad, India (On-Site)
Job Type: Full-Time
Category: Biostatistical Programming / Clinical Data Science
Job ID: R-232856
Posted Date: 18 December 2025
Job Overview
Amgen is seeking a Biostatistical Programming Senior Associate to join our expanding global Statistical Programming team in Hyderabad. This role provides a hands-on opportunity to perform complex statistical programming and analysis to support clinical trials and regulatory submissions. You will collaborate with cross-functional teams across regions, ensuring high-quality data analysis and reporting in adherence to global standards.
This position is ideal for experienced statistical programmers who are tech-savvy, detail-oriented, and thrive in a collaborative, fast-paced, and globally dispersed environment.
Key Responsibilities
Develop, validate, and maintain complex SDTM, ADaM, and other analysis datasets for both safety and efficacy
Perform statistical analyses and generate tables, listings, and figures (TLFs) using SAS and/or R
Prepare and review statistical programming specifications and regulatory submission documentation
Track and document programming activities and validation results to ensure data integrity and compliance
Collaborate with cross-functional teams globally, supporting clinical data quality, analysis, and programming requirements
Serve as a backup to the Study Lead Programmer (SLP) or assist with select SLP responsibilities
Apply best practices for CDISC SDTM, ADaM, and Define standards in dataset creation and reporting
Support automation, digital programming tools, and continuous improvement initiatives in statistical programming workflows
Required Qualifications
Bachelor’s degree in Biostatistics, Statistics, Mathematics, Computer Science, or other quantitative/scientific discipline
Minimum 4 years of relevant statistical programming experience in clinical development or pharmaceutical industry
Strong proficiency in SAS/STAT, and experience with clinical data manipulation, analysis, and reporting
Knowledge of the drug development lifecycle and clinical trial data structure
Familiarity with CDISC SDTM and ADaM standards and regulatory submission requirements
Ability to manage multiple tasks or projects across therapeutic areas with adherence to timelines
Excellent written and verbal English communication skills
Demonstrated ability to work effectively in a global, cross-cultural team environment
Preferred Qualifications
Master’s degree (MSc) or higher in Statistics, Biostatistics, Mathematics, or related quantitative/scientific discipline
Experience with open-source programming tools (R, Python) and automation platforms
Prior exposure to regulatory submissions for drug approval
Knowledge of data quality and compliance checking tools
Why Join Amgen
At Amgen, our mission is to serve patients by delivering innovative therapies worldwide. We are committed to the growth and well-being of our employees, offering:
Opportunities for professional development, learning, and career progression within a global organization
Inclusive and diverse culture fostering collaboration, innovation, and empowerment
Competitive total rewards package including health, financial, work-life balance, and career benefits
Amgen is a workplace where your contributions can make a global impact while advancing your career in biostatistical programming and clinical data science.
How to Apply
Qualified candidates are encouraged to apply via our careers portal. Candidates with strong experience but not meeting every requirement are also encouraged to submit their applications.
Gujarat :
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