Amgen Biomedical Data Stewardship Mgr in Cambridge, United Kingdom

Biomedical Data Stewardship Manager

  • Leading and facilitating new DES standards as requested with emphasis on SDTM

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

  • Developing and maintaining processes for the design and implementation of Data Element Standards (DES)

  • Manage 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 standards 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, SDTM, 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

Degree educated with proven clinical experience

Preferred Qualifications

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

  • Extensive work experience in data management, biostatistics or programming in Pharmaceutical / Biotechnology industry

  • Proven 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)

Closing date to apply: 24th January 2019