Biostatistical Programming Senior Associate

Responsibilities

• Perform hands-on statistical programming for the analysis and reporting of clinical trial data using SAS and/or R
• Create and validate complex SDTM and ADaM datasets, as well as safety and efficacy tables, listings, and figures
• Prepare statistical programming specifications and documentation required for regulatory submissions
• Maintain rigorous tracking and validation documentation to ensure data quality
• Collaborate with global cross-functional teams to develop and validate programs for checking data quality
• Assist with tasks of the Study Lead Programmer (SLP) or serve as a backup SLP

Requirements

• BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or a related quantitative field
• At least 4 years of statistical programming experience within a clinical development environment
• Working knowledge of CDISC SDTM standards and familiarity with CDISC ADaM and Define standards
• In-depth knowledge of SAS/STAT packages
• Strong ability to manipulate, analyze, and report complex clinical trial data
• Excellent oral and written English communication skills
• Ability to work effectively in a globally dispersed team environment

Preferred Qualifications

• MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative subjects
• Familiarity with open-source programming tools such as R or Python
• Experience with automation platforms and emerging technologies in statistical programming
• Prior experience with regulatory submissions for drug approval

Benefits

• Vast opportunities to learn and advance within a global organization
• A diverse and inclusive community of belonging
• Generous Total Rewards Plan including health, finance, wealth, and work/life balance benefits

About the Company

Amgen is a leading biotechnology company dedicated to unlocking the potential of biology to serve patients suffering from serious illnesses. By leveraging advanced human genetics and biologics manufacturing expertise, Amgen discovers and delivers innovative human therapeutics to millions of patients worldwide.