(Senior) SDTM Programmer

Role Summary

The (Senior) SDTM Programmer will be part of Biogen’s SDTM Development and Operations organization, evolving to fulfill Biogen’s SDTM needs with presence in the United States and Europe.

You will lead study-level SDTM programming activities and collaborate across Analytics, Data Science, and Biometrics to ensure timely, high-quality SDTM deliverables. You will represent SDTM Development and Operations in Biogen Portfolio Disease Unit discussions and ensure quality SDTM package delivery to the Statistical Programming group through oversight of the SDTM activities.

Responsibilities

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

Qualifications

• Required: Bachelor’s degree.
• Required: 2+ years relevant work experience with a focus on SDTM and statistical programming (4+ years’ experience for Senior SDTM Programmer consideration).
• Required: 2+ years proven data standards experience with a focus on SDTM and end-to-end data flow (3+ years’ experience for Senior SDTM Programmer consideration).
• Required: 2+ years of Pharmaceutical/Biotech/CRO industry experience.
• Required: Good knowledge of clinical data standards, regulatory submission requirements including current global landscape.
• Required: Working cross-functionally with Biometrics stakeholders.

Skills

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