Senior Statistical Programmer Analyst at Jobgether – United States
Jobgether
United States, United States
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About This Position
Senior Statistical Programmer Analyst
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.
Accountabilities:- 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, reviewers 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
Requirements:
- Bachelors or Masters 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
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
Why Apply Through Jobgether?
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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Job Location
United States, United States
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