Biostatistical Programming Senior Associate in Hyderabad, भारत

Amgen seeks a Biostatistical Programming Senior Associate in Hyderabad to perform statistical programming for clinical trials and regulatory submissions. The role involves SAS/R programming, dataset creation and validation, and collaboration with global cross-functional teams supporting integrated clinical development.

Responsibilities

• Perform statistical analysis and reporting of clinical trial data using SAS and/or R
• Create and validate SDTM, ADaM, and analysis datasets for safety and efficacy studies
• Generate and validate complex tables, listings, and figures for regulatory submissions
• Develop statistical programming specifications and related regulatory documentation
• Collaborate with cross-functional teams to develop and validate data quality check programs

Requirements

• BA/BSc or higher in biostatistics, statistics, mathematics, computer science, or related quantitative field
• Minimum 4 years statistical programming experience in clinical development environment
• Proficiency in SAS/STAT packages and complex clinical trial data manipulation
• Working knowledge of CDISC SDTM, ADaM, and Define standards
• Familiarity with data quality and compliance check tools
• Excellent oral and written English communication skills
• Ability to manage multiple projects across therapeutic areas and work in globally dispersed teams