Remote Senior SDTM Programmer/Analyst Consultant

Role Overview: The Senior SDTM Programmer provides expert oversight and creation of SDTM data deliverables for clinical analysis, reporting, and regulatory submissions.

Responsibilities include:

• Developing and validating SDTM datasets, Define.XML, SDRG, and aCRF documents.
• Collaborating with project teams, external vendors, and stakeholders to ensure data quality and standards compliance.
• Supporting submission processes using tools like Pinnacle 21 Enterprise.
• Continuously improving electronic submission workflows and providing tools for data traceability and quality assurance.
• Participating in industry best practice groups and departmental initiatives.

Qualifications & Skills:

• BA/BS in related fields with 3-5 years SAS programming experience in clinical trials; MS preferred.
• Strong SAS macro development skills, expertise in CDISC SDTM standards, and experience with regulatory submissions.
• Excellent interpersonal, technical writing, and project management skills.
• Knowledge of clinical data management and SDTM concepts; ability to translate strategy into actionable tasks.
• Preferred: Experience with SOPs, SDLC, cross-cultural collaboration, and project planning tools.

Key Attributes: Ability to work independently, ensure deliverable quality, adapt to evolving standards, and collaborate effectively across teams. The role requires a proactive approach to process improvement and compliance within a global clinical development environment.