Biomedical Data Stewardship Sr. Manager

Detailed Description Responsibilities:

  • Develop and maintain processes for the design and implementation of data element standards (DES) with emphasis on ADaM standards

  • Provide strategic direction in the adoption and implementation of CDISC ADaM standards with appropriate level of documentation

  • Ensure that Amgen decisions with respect to ADaM implementation are ADaM-compliant and are in line with industry guidance  

  • Manage standards content in a metadata repository (MDR)  

  • Identify and champion opportunities to improve efficiency and compliance via improved technological solutions, including process automation   

  • Liaise with cross-functional R&D groups to continually advance, and oversee standards, technical quality and consistent approaches in DES implementation  

  • Collaborate cross-functionally and within Data Stewardship to improve compliance with the evolving standards, processes and training relating to DES Track key metrics and provide reports of DES adherence

  • Provide DES expertise to stakeholders across R&D

  • Promote awareness of the role of the Data Stewardship organization, across R&D

  • Stay abreast of latest developments and requirements in the field of DES and regulatory guidance/practice

  • Contribute to resource and budget planning Lead and/or participate in the development and review of Amgen Policies, SOPs and other controlled documents

  • May participate in external activities (e.g. Industry, academic)

  • 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

  • Bachelor's degree in statistics/ biostatistics, programming, life science, computer science, business administration or related discipline or equivalent combination of education and experience

  • 8 or more years knowledge/experience in clinical research and development in a statistics and/or programming environment

  • Demonstrated effective communication skills (written and oral)

Preferred Qualifications

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

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

  • 5+ years’ experience in a global organization

  • Strong facilitation, influencing, and negotiation skills

  • Prior regulatory submission experience with SDTM/ADaM data and define.xml

  • Process improvement leadership