Cambridge, MA; RTP, NC; or remote

 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. 

Principle Responsibilities

  • Facilitates the implementation of data standards strategies within ADS and other functions as needed. Leads and/or participates in cross-functional initiatives to improve standards integration within the clinical data flow
  • Leads the development and rapid expansion of Therapeutic Area standards to enable efficient study development and the optimization of the end-to-end data flow (i.e. from CDASH to SDTM to ADaM with appropriate overarching Controlled Terminology).
  • Serves as SME in defining best practices for Biogen implementation of standard models (CDASH, SDTM, CT, ADaM, Define.xml) and 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 ADS 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 ADS and other functions in R&D.
  • Creates and delivers training content, newsletters etc. to support data standards awareness, adoption, utilization and compliance.

Qualifications

  • 8+ years relevant work experience with a focus on data management, statistical programming or data sciences
  • 4+ years in-depth data standards experience
  • Strong knowledge of CDISC standards, regulatory and drug submission requirements and current regulatory trends including global landscape
  • Deep understanding of drug development and biopharmaceutical industry
  • Strong project management skills, and the ability to effectively lead and collaborate with various business functions
  • High attention to detail including proven ability to manage multiple, competing priorities
  • Excellent oral and written communication as well as effective presentation skills
  • Demonstrated problem solving and conflict resolution

Education

  • Bachelor’s degree required.

Location  Cambridge, MA; RTP, NC; or remote

EMAIL CV directly to  jelena.raguz@biogen.com.