Amgen Careers 2026 | Biostatistical Programming Senior Associate Jobs Hyderabad

📋 Job Overview

• Company: Amgen India (AIN)
• Job Title: Biostatistical Programming Senior Associate
• Location: Hyderabad, Telangana, India
• Department: Global Statistical Programming
• Employment Type: Full-Time, Permanent
• Experience: 4+ Years of Statistical Programming in a Clinical Trial Environment
• Qualifications: BA/BSc, MSc, or higher degree in Statistics, Biostatistics, Mathematics, or Computer Science
• Tools Required: SAS (Base/Macros/Stat), R Programming, CDISC (SDTM/ADaM/Define.xml)

🎯 Key Responsibilities

As a Biostatistical Programming Senior Associate at Amgen, your tasks will include:

• Data Reporting & Analysis: Develop, write, and execute SAS and/or R programs to analyze and report complex clinical trial data.
• Dataset Creation & Validation: Build and validate complex SDTM and ADaM databases, covering both efficacy and safety data domains.
• TFL Generation: Program and validate complex tables, listings, and figures (TLFs) in adherence to statistical analysis plans (SAP).
• Regulatory Documentation: Draft technical programming specifications, Define.xml guidelines, and documentation required for regulatory agency dossier submissions.
• Study Lead Support: Assist Study Lead Programmers (SLP) in managing project milestones, data quality checks, and serve as backup lead as required.

To learn how clinical database programming and SAS statistics career tracks compare with clinical data management roles in terms of salary growth, check our article on Clinical SAS vs Clinical Data Management.

🎓 Required Qualifications & Skills

Educational Eligibility:

• Bachelor’s or Master’s degree in Biostatistics, Statistics, Mathematics, Computer Science, or related quantitative/scientific fields.

Core Professional Skills:

• At least 4 years of hands-on statistical programming experience within a clinical drug development environment.
• Expertise in SAS programming (macros, data step, SAS/STAT, and reporting procedures).
• Working knowledge of CDISC standards, particularly SDTM, ADaM, and Define.xml structures.
• Familiarity with clinical data quality assurance check tools (like Pinnacle 21).
• Prior exposure to open-source programming tools (R, Python) or regulatory drug submissions is highly preferred.

For statistical programmers analyzing compensation brackets, benefits, and international growth paths within top-tier biopharma companies, review our analysis on Healthcare Salary Trends: India vs USA.

📝 Resume Tips for Amgen Candidates

• State Standards Handled: Explicitly mention CDISC versions you have worked with (e.g. SDTM v1.4, ADaM v2.1) and Pinnacle 21 validation experience.
• Highlight R/Python integration: If you have programmed clinical outputs or created packages in R, list those libraries (e.g., ggplot2, Tidyverse) alongside your SAS skills.
• Include Submission Experience: Mention if you have contributed to NDA, BLA, or PMDA submission packages, including Define.xml reviews.

💬 Amgen Biostatistical Programming Interview Questions

• Q1. What is the fundamental difference between SDTM and ADaM standards?
  Answer Guidance: SDTM (Study Data Tabulation Model) is designed to organize and structure raw clinical trial data as collected, serving as a standardized database for regulatory submissions. ADaM (Analysis Data Model) is designed to support statistical analysis, containing derived variables and structured datasets optimized for generating tables, listings, and figures.
• Q2. How do you programmatically handle and document Define.xml validation errors?
  Answer Guidance: Validation errors are identified using tools like Pinnacle 21. If errors occur due to data structures, I modify the SAS programs to align with specifications. If the error is a false positive due to study-specific designs, I document a detailed explanation in the Reviewers Guide (SDRG/ADRG) to justify the exception to regulators.
• Q3. When performing dataset merges in ADaM, why is it critical to check for ‘many-to-many’ merges, and how do you prevent them?
  Answer Guidance: Many-to-many merges in SAS can create unintended cartesian products, duplicating observations and corrupting statistical calculations. To prevent this, I ensure merge keys uniquely identify observations in at least one dataset, and perform pre-merge checks using PROC FREQ or check the log for warning messages.

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❓ Frequently Asked Questions

Q. What is the location for this Biostatistical Programming position?
This is a full-time office position based at Amgen India’s offices in Hyderabad, Telangana, India.

Q. What is the minimum experience required to apply?
Candidates must have at least 4 years of clinical statistical programming experience within a drug development environment.

Q. Are open-source tools like R or Python required?
While SAS remains the primary tool, familiarity with R, Python, and open-source automation platforms is listed as a preferred skill.