Principal Statistical Programmer

Company: Global Biopharmaceutical Company
Location: Remote, United States
Work Arrangement: Remote
Engagement: Contract Consulting Role

The Opportunity

Brio has partnered with a global biopharmaceutical company advancing innovative therapies across neuroscience and oncology to recruit a Principal Statistical Programmer.

This consultant will provide technical leadership for clinical programming activities, translating statistical requirements into accurate, traceable, and submission-ready datasets and outputs. The role requires strong independent judgment, advanced SAS expertise, and the ability to coordinate programming delivery across internal and external teams.

Key Responsibilities

• Lead statistical programming activities for assigned clinical studies and development programs.
• Develop and validate SDTM and ADaM datasets, tables, listings, figures, and associated documentation.
• Translate protocols, statistical analysis plans, and reporting requirements into programming specifications and deliverables.
• Ensure programming outputs are accurate, reproducible, traceable, and consistent with applicable standards.
• Implement CDISC standards and contribute to data standards, specifications, and submission documentation.
• Develop and maintain define.xml, annotated CRFs, reviewer guides, and other regulatory deliverables.
• Create and manage programming plans, timelines, quality-control procedures, and delivery expectations.
• Review code, datasets, outputs, and documentation produced by internal programmers, CROs, and external partners.
• Collaborate closely with Biostatistics, Data Management, Clinical Development, Regulatory Affairs, and Medical Writing.
• Identify programming risks, resolve technical issues, and escalate matters that may affect timelines or quality.
• Support integrated analyses, regulatory submissions, health-authority questions, and post-submission activities.
• Contribute to programming standards, reusable tools, process improvements, and automation initiatives.

Qualifications

• Bachelor’s or advanced degree in statistics, biostatistics, mathematics, computer science, life sciences, or a related discipline.
• Extensive statistical programming experience supporting clinical development within biotechnology, pharmaceutical, or CRO environments.
• Advanced proficiency in SAS; experience with R or other programming languages is beneficial.
• Strong experience producing and validating SDTM and ADaM datasets and tables, listings, and figures.
• Thorough knowledge of CDISC standards, controlled terminology, define.xml, annotated CRFs, and reviewer guides.
• Demonstrated experience supporting regulatory submissions and responding to health-authority questions.
• Experience providing technical leadership, reviewing programming work, and overseeing CRO or external programming partners.
• Strong understanding of clinical trial data, statistical analysis plans, regulatory expectations, and programming quality controls.
• Ability to independently manage multiple priorities while maintaining accuracy, documentation, and delivery timelines.
• Oncology, neuroscience, rare-disease, or late-stage clinical development experience is beneficial.
• Strong communication and collaboration skills within remote, cross-functional teams.

Why Consider This Opportunity?

• Technical ownership: Set and maintain high standards for programming quality, traceability, and reproducibility.
• Submission relevance: Produce datasets and analytical outputs supporting important development and regulatory milestones.
• Portfolio exposure: Contribute across clinical programs within neuroscience, oncology, and rare diseases.
• Specialist influence: Apply advanced programming expertise to complex analytical and submission requirements.
• Remote flexibility: Deliver senior-level technical leadership through a fully remote consulting engagement.

Interested?

Submit your resume to Brio to learn more about the organization, its development portfolio, and the consulting engagement. Additional details regarding contract duration, allocation, compensation, and the complete job description will be provided following an initial resume review.

Brio Resource Group partners with emerging and established life sciences companies to recruit executives, functional leaders, and specialized professionals.