In this role, we are looking for individuals with a strong understanding of end-to-end standards and data flow. Keeping the “end-in-mind” as we partner within the Biomedical Data Stewardship (BMDS) team to ensure the correct data is being collected with our standard protocol and SAP language and data collection standards for analysis and reporting purposes. The position will primarily work within BMDS, but may also collaborate with statisticians and statistical programmers at Amgen to promote the usage of standards. This role will have an opportunity to work across Amgen’s therapeutic areas to create and maintain clinical trial data standards. This role will also have the opportunity for the development of a standards data repository connecting the ADaM standards with the table, figure, and listings standard specifications.
GCF: NA
EW: Contract Worker
Duration: Start ASAP with 1 Year with option to renew up to 3 years
Department: BMDS
Supervisor: Kim Musgrave
Ideal candidate:
Extensive clinical trial support with emphasis on the creation of specifications for ADaM data and tables, figures and listings including the usage of standards, 10 or more years of pharmaceutical/biotech experience in drug development and a doctoral degree or master’s degree with relevant experience.
What you will do
In this role, we are looking for individuals with a strong understanding of end-to-end standards and data flow. Keeping the “end-in-mind” as we partner within the Biomedical Data Stewardship (BMDS) team to ensure the correct data is being collected with our standard protocol and SAP language and data collection standards for analysis and reporting purposes. The position will primarily work within BMDS, but may also collaborate with statisticians and statistical programmers at Amgen to promote the usage of standards. This role will have an opportunity to work across Amgen’s therapeutic areas to create and maintain clinical trial data standards. This role will also have the opportunity for the development of a standards data repository connecting the ADaM standards with the table, figure, and listings standard specifications.
In this role you will:
• Build a comprehensive understanding of Amgen’s data standards structure across stages of development
• Build a comprehensive understanding of the Metadata Repository (MDR) product
• Develop mappings between Amgen’s ADaM and tables, figures, and listings standards within MDR
• Develop and maintain guidance documents supporting the analysis and reporting standards
• Ensure that Amgen decisions with respect to ADaM implementation are ADaM-compliant and are in line with industry and regulatory guidance
• Provide input to continuously improve the management of analysis and reporting standards and metadata
What we expect of you:
Basic Qualifications:
• Doctoral degree and 4 years clinical trials experience OR
• Master’s degree and 6 years clinical trials experience OR
• Bachelor’s degree and 8 years clinical trials experience
• Proficient in CDISC ADaM modeling and CDISC IGs and TAUGs
• Effective communication and collaboration skills
Preferred Qualifications:
• 10 or more years of pharmaceutical/biotech experience in data management, biostatistics or programming
• Proven standards development experience
• Experience in designing, analyzing, and reporting clinical trials
• Independent and self-motivated