Be Part of a High-Performing Team

This opportunity supports a leading organization in the biotechnology and pharmaceutical space known for advancing meaningful therapies through scientific rigor and data-driven decision-making. The clinical development groups within this organization operate with strong technical excellence, structured processes, and high accountability. The team is composed of seasoned statistical programmers and biostatistics professionals who collaborate closely to drive study execution, ensure high-quality analysis outputs, and maintain compliance with industry standards. Their work environment blends independence with structured collaboration, especially during critical program phases such as database locks and regulatory milestones.

What’s In Store for You

This hybrid role provides the flexibility of remote work with designated onsite sessions during high-impact phases of development. The position offers exposure to vital clinical programs, opportunities to refine technical programming skills, and the chance to contribute directly to data that supports regulatory deliverables and clinical strategy.

How You Will Make an Impact

• Develop, validate, and maintain high-quality SDTM and ADaM datasets aligned with CDISC standards.
• Produce and validate Tables, Listings, and Figures for clinical study reporting.
• Interpret study protocols and statistical analysis plans to guide programming approaches.
• Apply advanced SAS programming techniques and macro development to streamline workflows.
• Conduct thorough validation and QC of all programming outputs.
• Support regulatory-facing activities such as spec development, CRF annotation, and preparation of submission-ready materials.
• Manage multiple assignments independently while maintaining accuracy and timelines.

Do You Bring Proven Success in Clinical SAS Programming?

Required Skills & Experience

• 5–8+ years of clinical/statistical programming experience in pharma or biotech.
• Expert-level SAS programming, including macro development and advanced data manipulation.
• Strong hands-on experience with CDISC standards, including SDTM and ADaM.
• Demonstrated ability to produce and validate TLFs.
• Experience interpreting SAPs and understanding study design and statistical workflows.
• Ability to independently drive programming tasks with minimal oversight.
• Strong analytical mindset with the ability to question and clarify specifications.
• SAS certification is a plus.

Preferred Background

• Exposure to regulatory submissions, including FDA workflows.
• Experience with spec building and CRF annotation.