Senior Statistical Programmer Analyst

Jobgether

3d • Remote

About The Position

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Statistical Programmer Analyst Contractor in the United States. This role provides a unique opportunity to contribute to early-stage immuno-oncology clinical programs by leading the development and execution of statistical programming and analyses. You will ensure submission-ready study data packages, maintain compliance with CDISC standards and FDA guidance, and support internal and external stakeholders across biostatistics, clinical operations, and regulatory teams. The position offers hands-on technical work with SAS, R, Python, and Unix, while influencing program quality, efficiency, and innovation. You will operate in a collaborative, fast-paced environment, managing complex datasets, generating TFLs, and creating SDTM/ADaM outputs for regulatory submissions and publications. This contract role allows for remote work within the United States, providing both flexibility and the chance to make a tangible impact on the clinical development pipeline.

Requirements

• Bachelor’s or Master’s degree in Statistics, Mathematics, Epidemiology, Computer Science, Bioinformatics, or related field
• 8+ years of programming experience in biotechnology or pharmaceutical clinical trial environments
• Expert-level skills in SAS programming, with strong experience in R, Python, Unix scripts, and macro development
• Solid understanding of CDISC standards (SDTM, ADaM), controlled terminology, and regulatory submission requirements
• Ability to translate complex clinical and statistical problems into clear, functional code and tools
• Experience with software development and testing, project management, and programming best practices
• Knowledge of ICH-GCP, 21 CFR Part 11, and relevant clinical R&D concepts
• Excellent written and verbal communication skills, with the ability to manage priorities and collaborate effectively

Responsibilities

• Develop specifications and execute programs for internal data reviews, publications, exploratory, post-hoc, and regulatory analyses
• Ensure study data packages comply with CDISC standards (SDTM, ADaM) and health authority reporting requirements
• Collaborate with clinical data management to review case report forms, database, and data transfer specifications
• Create and review SDTM/ADaM mapping specifications, reviewer’s guides, and define.xml files
• Generate or validate TFLs to support statistical analyses for clinical studies, regulatory submissions, and publications
• Prioritize analytical deliverables strategically, including study-level or integrated analyses for safety signal detection or business needs
• Manage timely and quality delivery of CRO-generated analysis results

Benefits

• Competitive contract compensation
• Flexible remote work within the United States
• Exposure to cutting-edge immuno-oncology research and clinical development
• Opportunity to work collaboratively with a growing Biometrics team
• Professional growth through experience with regulatory submissions and complex statistical programming

What This Job Offers

• Career Level: Mid Level