The Principal Analyst, Data Standards, drives the development, implementation and maintenance of Analytics and Data Sciences’ (ADS) clinical data standards capabilities. Successful candidate serves as an SME in defining best practices for Biogen’s implementation of standard models (e.g. CDISC CDASH, SDTM, Controlled Terminology, ADaM, Define.xml) to ensure drug submissions are compliant with industry regulations. He/she 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 ADS and other R&D functions. He/she will be instrumental in facilitating the rapid expansion of Therapeutic Area (TA) standards to enable end-to-end data flow optimization. Acting as a consultant, he/she supports and educates colleagues and clinical study teams across ADS. He/she participates in external industry data standards development teams, as appropriate, and contributes to the development of clinical data standard models on ADS's behalf.
Location Cambridge, MA; RTP, NC; or remote
EMAIL CV directly to firstname.lastname@example.org.