Amgen Biomedical Data Stewardship Mgr in Harrisburg, Pennsylvania

  • Designing, defining, and reviewing data capture standards (forms and edit checks) for inclusion in library of data standards

  • Consulting with study teams for study-level implementation of data capture standards

  • Developing and maintaining processes for the design and implementation of data capture standards

  • Manage data capture standards content in a metadata repository (MDR)

  • Review and audit study-level implementation of standards content for compliance

  • Develop and compile metrics for communicating outcomes of data standard compliance reviews/audits

  • Provide additional support to study teams for the adoption of standards

  • Drive and facilitate the expansion of standards across Amgen Global Development Key Skills / Knowledge:

  • In depth knowledge/experience of data collection, analysis, and reporting in drug development and clinical trials processes

  • Collaborating in global cross-functional teams

  • Experience in project management, documentation writing, training, and compliance

  • Interest in process improvement methodologies

  • Use of software and data applications within drug development

  • Appreciation of computer system architecture and hardware

  • Experience with utilizing metadata repository systems to curate and maintain standards-related assets

Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of clinical experience

OR

Bachelor's degree and 5 years of clinical experience

OR

Associate's degree and 10 years of clinical experience

OR

High school diploma / GED and 12 years of clinical experience

Preferred Qualifications

  • Bachelor's or Master's degree in statistics/ biostatistics, programming, life science, computer science, business administration or related discipline

  • 5+ years cumulative work experience in data management, biostatistics or programming in Pharmaceutical / Biotechnology industry

  • 3+ years' experience in a global organization

  • Strong facilitation, influencing, and negotiation skills

  • Builds and maintains relationship for collaboration

  • Project planning and management

  • Process improvement leadership

  • Participation in the development of policies and SOPs

  • Effective communication skills (written and oral)

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, or disability status.