Biostatistical Programming Manager

Join Amgen’s Mission of Serving Patients. At Amgen, we are dedicated to serving patients living with serious illnesses and have been pioneers in biotechnology since 1980. We focus on oncology, inflammation, general medicine, and rare disease to reach millions of patients each year.

Drive Case Report Form design and data collection strategy within the Clinical Study Team to influence purposeful data collection decisions and ensure successful analysis and submission. Review study SDTM datasets and related specifications, provide CDISC SDTM expertise, author and review SDTM submission files, conduct conformance checks, audit pivotal snapshots, support global standards content management, and develop cross‑functional case report forms. Telecommuting may be permitted.

• Design and supervise CRF creation and review, ensuring alignment with CDISC SDTM standards.
• Apply project‑management principles to coordinate timelines, deliverables and automation efforts for SDTM production.
• Collaborate with external stakeholders (FSPs, CROs, and contingent workers) to deliver study‑level programming outputs such as SDTM domains, Define.xml, and aCRF.
• Analyze clinical trial datasets to support regulatory submissions and internal analysis across study phases.
• Prepare submission‑ready datasets and documentation per CDISC and regulatory requirements, perform data mapping and ad‑hoc analyses.
• Program in statistical languages (SAS, R, Python) to develop and validate clinical data outputs.
• Design and build automation tools to improve processes related to SDTM production across the portfolio.

• Master’s degree (or foreign equivalent) in Applied Science, Mathematics, or a related field.
• Completion of a university‑level course, research project, internship, or one year of experience in biostatistical programming or clinical data management.
• Experience creating and managing annotated CRFs, reviewer’s guides, and conformance documentation using controlled terminology and CDISC SDTM implementation guides.
• Proficiency in project‑management tools and coordination of cross‑functional dependencies to ensure timely report completion.
• Ability to collaborate with external stakeholders (FSPs, CROs, contingent workers) to deliver study‑level programming outputs.
• Hands‑on experience working with clinical trial datasets to support regulatory submissions across different study phases.
• Strong data mapping and ad‑hoc analysis skills following CDISC and regulatory standards.
• Programming expertise in SAS, R, and Python for developing and validating clinical data outputs.
• Experience designing and developing automation tools for SDTM production across the portfolio.

• Competitive salary $–$ per year, plus stock options, retirement plans, medical benefits, life and disability insurance, and an annual bonus or other incentive compensation.
• Comprehensive benefits package including retirement and savings plan with generous company contributions, group medical, dental, vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program and, for field sales representatives, a sales‑based incentive plan.
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans.
• Flexible work models, including remote and hybrid work arrangements where possible.

Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will provide reasonable accommodation to applicants and employees who require it.