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Principal Analyst, Data Standards - CDASH

Cambridge, MA

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.

Principal Accountabilities:

  • Facilitates the implementation of data standards strategies within CDS and other functions as needed. Leads and/or participates in cross-functional initiatives to improve standards integration within the clinical data flow.
  • Serves as SME in defining best practices for BIIB implementation of standard models (SDTM, CT, ADaM, CDASH, Define.xml), ensuring submission compliance. Establishes and manages governance processes for data standards models.
  • Consults with teams to facilitate improved decision-making and problem-solving to aid in consistent application of data standards.
  • Represents Biogen and CDS on external industry-facing data standards development teams. Participates in external initiatives to proactively adopt industry trends and anticipate regulatory needs.
  • Coordinates communication and education with internal stakeholders across DS&O, Biostatistics, and other functions within Global Development as well as external.
  • Creates training content for data standards execution.

EMAIL CV directly to sheri.richter@biogen.com or click link below to apply online.

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