Data Standards and RWD Specialist

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Basic Qualifications:
•    BA/BSc or higher degree with strong analytic skills and a solid working knowledge of CDISC SDTM standards. Knowledge of ADaM standards is helpful, but not required 
•    At least 5 years of experience using CDISC SDTM standards to map CRF, Lab, COA/PRO, and ECG data   
•    Working knowledge of CRF annotation creation, controlled terminology management, and SDTM Reviewer’s Guide requirements
•    Understanding of drug development processes, clinical trial life cycle, internal data standards, and regulatory submission data requirements
•    Understanding of Real-World Data (RWD) sourced from Electronic Health Records, patient charts, or compiled insurance databases 
•    Ability to work effectively and successfully in a remote, globally dispersed team environment with cross-cultural partners. 
•    Ability to work effectively on multiple tasks or projects simultaneously 
•    Excellent oral and written English communication skills

Preferred Qualifications:
•    >5 years of experience using CDISC SDTM standards to map collected data, annotate CRFs and manage controlled terminology 
•    Familiarity with the wider data standards landscape, including how data standards facilitate the Regulatory application review process 
•    Familiarity with SAS programming and an understanding of processes which support mapping of collected data to SDTM, SDTM data to ADaM, and ADaM to analysis outputs
•    Thorough understanding of drug development processes and clinical trial life cycle, including regulatory submissions  

Key Responsibilities include but not limited to:
•    Provide overall SDTM consultancy, mapping guidance, P21 issues consultation, and Reviewers Guide review in support of submissions which include RWD formatted to SDTM as part of a Regulatory filing on study designs utilizing RWD
•    Build a comprehensive understanding of Amgen’s data standards structure across clinical trials, with the goal of eventually building new RWD data standards
•    Serve as a contributing member to the RWD Standards Collaboration team
•    Maintain a pulse on industry working group progress on RWD and/or RWE, specifically in areas of quality, reusability, and submission of RWD
•    Provide SDTM training and support to the RWD programming lead and team
 

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