Senior SDTM Programmer – Lead SDTM Deliverables & Standards

Biogen, Inc.; United States; Remote; USD 90,000 - 117,000; Full time

Benefits offered by this job

Medical, Dental, Vision & Life

Fitness reimbursement

Disability insurance

Paid vacation

Company holidays

Sick time

Parental leave

401(k) match

Employee stock purchase plan

Tuition reimbursement

Employee resource groups

Job summary

Biogen is seeking an (Senior) SDTM Programmer to join the SDTM Development and Operations team with presence in the United States and Europe. You will lead study-level SDTM programming activities, collaborate with Analytics, Data Science, and Biometrics to ensure timely, high-quality deliverables, and oversee SDTM work across studies.

The role emphasizes data standards expertise, SDTM end-to-end data flows, and potential Senior level consideration, with a base salary range and bonus

Qualifications

• 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.)
• 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.)
• 2+ years of Pharmaceutical/biotechnology/CRO industry experience required.
• Good knowledge of clinical data standards, regulatory submission requirements including current global landscape.
• Working cross functionally with Biometrics stakeholders.

Responsibilities

• Lead study level SDTM programming activities and deliverables (annotated CRF, specifications, datasets, define.xml, Study Data Reviewers Guide, etc.).
• Collaborating cross-functionally within Analytics and Data Science, you will work with other study leads within the Biometrics organization 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.

Skills

SAS programming

Lead experience

Clinical data understanding

Cross-functional collaboration

Education

Bachelor’s degree

Tools

SAS

Job description

Biogen is seeking an (Senior) SDTM Programmer to join the SDTM Development and Operations team with presence in the United States and Europe. You will lead study-level SDTM programming activities, collaborate with Analytics, Data Science, and Biometrics to ensure timely, high-quality deliverables, and oversee SDTM work across studies.

The role emphasizes data standards expertise, SDTM end-to-end data flows, and potential Senior level consideration, with a base salary range and bonus