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Biostatistical Programming Senior Associate

By Admin · Biostatistics & Statistical Programming

HYDERABAD (IN)ONSITEPOSTED: 9/21/2026
TECHFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
Amgen

ROLE OVERVIEW

Perform hands-on statistical programming activities to support complex statistical data analysis of clinical studies and regulatory submissions.

ROLE DEFINITION & RESPONSIBILITIES

  • •Analysis and reporting of clinical trial data using SAS and/or R
  • •Creation and validation of complex SDTM, ADaM, and analysis datasets
  • •Creation and validation of complex tables, listings, and figures
  • •Prepare statistical programming specifications and regulatory submission documents
  • •Maintain tracking and validation documentation
  • •Collaborate with cross-functional teams and serve as backup Study Lead Programmer
Reporting Hierarchy: Reports to Biostatistical Programming Lead • Team size: 6-12

* Role responsibilities and qualifications synthesized based on industry benchmark standards.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or related quantitative field
  • At least 4 years of statistical programming experience in a clinical development environment
  • Familiarity with drug development life cycle and clinical trial data manipulation
  • Working knowledge of CDISC SDTM, ADaM, and Define standards
  • In-depth knowledge of SAS/STAT packages
  • Excellent communication skills

PREFERRED QUALIFICATIONS

  • •MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative subjects
  • •Familiarity with open-source programming tools (R, Python) and automation platforms
  • •Prior regulatory submission experience for drug approval

REQUIRED VERIFIED SKILLS

SAS
R
SDTM
ADaM
CDISC Standards
Clinical Data Analysis
Statistical Programming

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Health insurance, PF, Paid leave, Global wellness benefits
Competitive corporate compensation benchmarked against top-tier biotechnology and pharmaceutical capability centers in India.

ORGANIZATION CONTEXT & CULTURE

Amgen is a leading global biotechnology company dedicated to discovering, developing, and delivering innovative human therapeutics for serious illnesses.

TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
Culture: Empowering teammates to bring ideas to the table and act together to serve patients worldwide.

EXPECTED CAREER ROADMAP

Clear career progression pathways into Lead Programmer, Statistical Programming Manager, or Director roles.

APPLICATION ADVISORY

Highlight your hands-on experience with CDISC standards (SDTM/ADaM) and clinical trial data programming using SAS or R.

READY TO SUBMIT?

Verify your capability profile and matching credentials before submitting direct applications.