Principal Analyst, SDTM Data Standards

Job Description

The Principal Analyst, SDTM Data Standards, drives the development, implementation and maintenance of clinical data SDTM standards capabilities. Successful candidate serves as an SDTM SME in defining best practices for Biogen’s implementation of standard models (e.g. CDISC SDTM, Controlled Terminology, Define.xml) to ensure drug submissions are compliant with industry regulations. The candidate will work very closely with SDTM Leads and be able to provide detailed SDTM mapping guidance for EDC and complex third party data and execution of SDTM governance requests. He/she leads or participates in cross-functional teams to coordinate data standardization efforts across the Quantitative Sciences and Development Organization (QSDO) 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 an SDTM consultant, he/she supports and educates colleagues and clinical study teams across QSDO. He/she participates in external industry data standards development teams, as appropriate, and contributes to the development of clinical data standard models on QSDO's behalf. Experience enabling metadata driven automation capabilities and tool integrations is a plus.

Principle Responsibilities

• The candidate will work very closely with SDTM Leads and be able to provide detailed SDTM mapping guidance for EDC and complex third party data and execution of SDTM governance requests. Serves as SME in defining best practices for Biogen implementation of standard models (CDASH, SDTM, CT, Define.xml) and ensuring submission compliance.

• Leads the development and rapid expansion of SDTM Therapeutic Area standards to enable efficient study development and the optimization of the end-to-end data flow (i.e. from CDASH to SDTM with appropriate overarching Controlled Terminology).
• Consults with teams to facilitate improved decision-making and problem-solving to aid in consistent application of data standards.
• Represents Biogen and QSDO 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 QSDO and other functions in R&D.
• Creates and delivers training content, newsletters etc. to support SDTM standards awareness, adoption, utilization and compliance.

Who You Are:

You are person who considers themselves an SDTM Subject Matter Expert. You are someone who is passionate about data, data structures, data transformations and standardization of clinical data. You are active in contributing to the CDISC working groups/community.

Qualifications

• 6+ years relevant work experience with a focus on data management, statistical programming or data sciences.
• 4+ years in-depth data …