Be Part Of A High-Performing Team:

Join a growing clinical programming function within a science-driven biopharmaceutical organization developing therapies for patients with serious and rare diseases. This newly established team is bringing critical SDTM programming capabilities in-house and works closely with data management, biostatistics, and statistical programming. The environment is collaborative, technically rigorous, and well suited to an experienced programmer who enjoys building reliable clinical-data solutions while helping shape new internal processes.

What's In Store For You:

Engagement: W2 only (no C2C/1099)

This is a fully remote, 12-month consulting assignment open to candidates located anywhere in the United States. Availability during Eastern Time business hours is preferred.

The role offers the opportunity to become one of the early members of a growing clinical programming team and contribute directly to the organization’s transition from outsourced SDTM programming to an internal delivery model. A contract extension may be possible based on performance and business needs, although permanent conversion is not currently planned.

How You Will Make An Impact:

• Create production-quality SDTM datasets using both SAS and R.
• Independently perform quality control and validation of SDTM datasets.
• Develop dataset specifications using CDISC standards and current SDTM Implementation Guides.
• Create annotated CRFs, including domain mappings, annotation boxes, controlled terminology, and page-level placement.
• Apply existing team macros and programming utilities to support annotated CRF and SDTM production.
• Develop SAS- and R-based listings and reports supporting medical monitoring, clinical data management, and statistical endpoint monitoring.
• Perform clinical-data checks, reconciliations, and issue investigation as assigned.
• Collaborate closely with data managers, biostatisticians, statistical programmers, and clinical-study stakeholders.
• Help establish scalable internal standards, workflows, and quality practices as SDTM programming transitions in-house.
• Manage multiple study deliverables independently while maintaining accuracy, traceability, and timely execution.

Do you bring proven success in SDTM programming with both SAS and R?

• Approximately 8–10 years of hands-on clinical programming experience in pharmaceutical, biotechnology, CRO, or related regulated clinical environments.
• Strong production programming proficiency in both SAS and R.
• Demonstrated experience creating and independently quality-checking SDTM datasets.
• Strong knowledge of CDISC standards and current SDTM Implementation Guides.
• Hands-on experience creating annotated CRFs, including page-level annotations and terminology mapping.
• Ability to use established macros, functions, and programming utilities.
• Experience translating raw clinical data, CRFs, specifications, and programming standards into compliant SDTM deliverables.
• Strong analytical, troubleshooting, documentation, and quality-control skills.
• Ability to work independently as an individual contributor in a small and evolving team.
• Strong written and verbal communication skills.
• Experience with JReview is highly preferred.
• Experience with Shiny, Pharmaverse, or R Markdown is highly desirable.
• Exposure to SQL programming is preferred.
• Experience supporting medical monitoring, data-management reports, reconciliations, or statistical endpoint monitoring is beneficial.

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