Biostatistical Programming Manager

Responsibilities

• Serve as the Study Lead Programmer (SLP) for one or more studies, managing end-to-end statistical programming activities.
• Set programming strategies to ensure timelines, quality, and compliance for all study deliverables.
• Lead and manage a team of statistical programmers, assigning tasks and providing technical guidance.
• Create and maintain programming specifications, including SDTM and ADaM standards.
• Represent the Global Statistical Programming (GSP) function at Clinical Study Team (CST) meetings.
• Participate in cross-functional activities such as CRF development, database specifications review, and data quality checks.
• Perform hands-on statistical programming for complex deliverables and manage the technical aspects of projects.
• Coordinate data issue reporting and resolution across the study team.

Requirements

• BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or a related quantitative field.
• At least 8 years of statistical programming experience within a clinical development environment.
• In-depth knowledge of CDISC SDTM, ADaM, and Define standards.
• Advanced SAS analysis and reporting skills, including experience with SAS/STAT packages.
• Strong project management skills with the ability to lead multiple projects and teams effectively.
• Excellent oral and written English communication skills.
• Proven ability to work successfully within globally dispersed, cross-cultural teams.

Preferred Qualifications

• MSc or higher degree in statistics, biostatistics, or mathematics.
• 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.

About the Company

Amgen is a leading global 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, develops, and delivers innovative human therapeutics to millions of patients worldwide.