Full-Time SDTM Programmer

About This Role The Study Data Tabulation Model (SDTM) Programmer will be part of the SDTM Development and Operations organization.

What You’ll Do

• Lead study level SDTM programming activities and deliverables (annotated Case Report Form (aCRF), specifications, datasets, define.xml, Study Data Reviewers Guide, etc.).
• Collaborate cross-functionally within Analytics and Data Science, working with other study leads within the Biometrics organization to ensure timely and quality SDTM deliverables for the study.
• Represent SDTM Development and Operations (Dev & Ops) in the Biogen Portfolio Disease Unit (DU) discussions.
• Ensure quality SDTM package delivery to the Statistical Programming group through programming and oversight of the study SDTM activities.

Who You Are

• Clinical SAS Programmer with some Lead experience or looking to lead a study
• Passionate about data, data structures, data transformations and taking/learning about initiatives using Analytics to optimize the transformation of clinical data.
• Experienced in SAS and keen to explore technologies beyond SAS in the clinical trial space.

Required Skills

• Bachelor’s degree
• 2+ years relevant work experience with a focus on SDTM and statistical programming
• 2-5 years proven data standards experience with a focus on SDTM and end to end data flow
• Pharmaceutical/biotechnology/CRO industry experience
• Good knowledge of clinical data standards, regulatory submission requirements including current global landscape
• Working cross functionally with Biometrics stakeholders

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