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Biostatistical Programming Senior Associate

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Amgen

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Location:
India , Hyderabad

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

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Job Description:

The Biostatistical Programming Senior Associate will work in Amgen's Global Randomization and Blinding (GRB) organization

Job Responsibility:

  • Creating and delivering Participant and Investigational Product (IP) randomization lists meeting specifications per randomization requests
  • Perform the duties of a Study Randomizer as needed
  • Write and validate SAS programs to verify randomization assignments and dose decisions performed by an Interactive Response Technology (IRT) system throughout the conduct of a clinical trial
  • Function as a study programmer to manage IRT data transfer activities
  • Act as a gatekeeper for IRT data transfers into Amgen’s secure File Transfer Protocol (sFTP) locations
  • Understand and execute both department and study level macros and utilities
  • Ongoing verification of electronic systems used to execute randomization schedules and dosing algorithms
  • Ensuring procedures are followed to maintain the study blind per Amgen Study Operating Procedures (SOPs) throughout the lifecycle of a study
  • Maintaining accurate and complete documentation of randomization and blinding activities and communications
  • Assist with study and systems audits by internal and external bodies and respond to audit questions and findings
  • Participate in the development and review of GRB policies, manuals, SOPs and other controlled documents
  • Cross functional training and presentations

Requirements:

  • 5-9 years of overall experience
  • BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or related subject
  • At least four years of statistical programming experience in relevant career statistical programming experience in a clinical development environment
  • Biostatistical programming using SAS version 8.2 and higher or other programming languages (e.g. R or Python)
  • Understanding of computer operating systems, including UNIX, preferred
  • Project planning and management
  • Basic understanding of IRT systems preferred
  • Drug development processes and operations

Nice to have:

  • MSc or higher degree in statistics, biostatistics, mathematics, or related subject
  • Six years of clinical research programming experience
  • Drug development in related industries
  • Project planning
  • Process improvement participation
  • Team participation and effectiveness

Additional Information:

Job Posted:
May 14, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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