The Principal Analyst, Data Standards drives the development, implementation, and maintenance of Biometrics’ clinical data standards capabilities. Successful candidate serves as CDASH SME in defining best practices for BIIB implementation of standard models (e.g., CDASH, SDTM, CT, ADaM, Define.xml) to ensure drug submissions compliant with industry regulations. They will apply an industry-facing focus to foster a consistent approach to employ clinical data standards and address governance requests. He/she leads or participates in cross-functional teams to coordinate data standardization efforts across DS&O, Biostatistics and other impacted Global Development functions. Acting as a consultant, he/she supports and educates colleagues across DS&O, Biostatistics, and clinical study teams and participates in external industry data standards development teams as appropriate, contributing to the development of clinical data standard models on DS&O’s behalf. Communicating across DS&O, Biostatistics, and clinical study teams is a critical component of the Principal Analyst, Data Standard role.
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