Manager, Clinical Programming - SDTM and R/SAS #3635027

Be Part Of A High-Performing Team:

Join a science-driven biopharmaceutical organization focused on developing meaningful therapies for patients with serious and rare diseases. This role sits within a collaborative Biometrics function that partners closely with clinical development, medical monitoring, data management, and statistical programming teams. The environment is highly technical and quality-focused, with an emphasis on reliable clinical data, regulatory-ready standards, and cross-functional collaboration.

What's In Store For You:

Engagement: W2 only (no C2C/1099)

This is a full-time, 12-month consulting opportunity supporting clinical development programs within an established Biometrics organization. The position offers exposure to multiple clinical programming workstreams, including SDTM dataset development, medical monitoring outputs, annotated CRFs, and modern R-based clinical reporting tools.

How You Will Make An Impact:

• Provide clinical programming support across medical monitoring, clinical data management, statistical programming, and endpoint-monitoring activities.
• Create dataset specifications and programming solutions aligned with CDISC SDTM Implementation Guide requirements.
• Develop, maintain, and validate regulatory-compliant SDTM datasets.
• Produce and maintain annotated case report forms based on approved SDTM specifications.
• Develop clinical outputs used by medical monitors, data managers, and statistical stakeholders to evaluate study quality and patient data.
• Build and maintain reusable SAS macros, R functions, and other programming utilities.
• Design, test, and implement technical solutions that address complex clinical-study requirements.
• Manage multiple programming assignments while maintaining accuracy, documentation quality, and delivery timelines.
• Collaborate effectively with clinical, biometrics, and technical stakeholders while independently driving assigned deliverables.

Do you bring proven success in clinical programming and CDISC standards?

• Bachelor's degree in a scientific, technical, statistical, computer science, or related discipline.
• Approximately 5-10 years of clinical programming experience within pharmaceutical, biotechnology, clinical research, or a closely related regulated environment.
• Advanced programming expertise in both R and SAS.
• Strong SQL programming skills for clinical-data extraction, transformation, validation, and analysis.
• Hands-on experience developing and validating CDISC-compliant SDTM datasets.
• Strong working knowledge of the SDTM Implementation Guide and annotated CRF development.
• Experience creating programming specifications, reusable macros, functions, and clinical-study utilities.
• Ability to independently design, develop, test, troubleshoot, and document complex programming solutions.
• Strong written and verbal communication skills with the ability to work across medical, data management, and statistical programming teams.
• Demonstrated ability to manage competing priorities and deliver accurate work within established timelines.
• Experience with JReview is highly preferred.
• Experience with Shiny, Pharmaverse, or R Markdown is preferred.
• Exposure to Python, VBA, C , or other programming languages is helpful.

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