Biostatistical Programming Senior Associate in Hyderabad, भारत

Amgen seeks a Biostatistical Programming Senior Associate in Hyderabad to perform statistical programming for clinical trial data analysis and regulatory submissions. The role involves creating and validating datasets, tables, and figures using SAS and R, with responsibility for complex clinical study programming across global teams.

Responsibilities

• Perform clinical trial data analysis and reporting using SAS and R programming
• Create and validate SDTM, ADaM, and analysis datasets for safety and efficacy assessments
• Generate and validate complex tables, listings, and figures for clinical studies
• Prepare statistical programming specifications and regulatory submission documentation
• Collaborate with cross-functional global study teams on data quality and programming tasks

Requirements

• Bachelor's degree or higher in biostatistics, statistics, mathematics, computer science, or related quantitative field
• Minimum 4 years of statistical programming experience in clinical development environments
• Proficiency with SAS/STAT packages and strong CDISC SDTM, ADaM, and Define standards knowledge
• Demonstrated ability to manipulate, analyze, and report complex clinical trial data accurately
• Experience with data quality and compliance check tools
• Fluent written and oral English communication skills
• Ability to manage multiple projects across therapeutic areas in global team settings