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. #LI-CL1 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Senior Statistical Programmer Analyst
Location
United States
Posted
7 days ago
Salary
Not specified
Job Description
Role Description
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.
- 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
Qualifications
- 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
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
Job 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
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
Related Guides
Related Categories
Related Job Pages
More Data Scientist Jobs
The Principal Data Scientist is a senior technical leader responsible for designing advanced analytics solutions, developing machine learning models, and guiding data-driven strategies across the organization. This role combines deep technical expertise with strategic thinking to...
The Advanced Case Escalations, ACE, team is responsible for identifying and resolving the systemic gaps that drive executive escalations. We operate at the intersection of Support, Product, Policy, and Operations, conducting structured root cause analyses on high-impact cases and...
Data Scientist
Mackin TalentRevolutionizing the workforce talent industry with quality employees, industry leading benefits & client support.
Data Scientist producing innovative solutions using exploratory data analysis
Onyx Government Service is seeking a Senior Enterprise Technical Lead who is a hands-on expert in data analytics, visualization, and AI-driven solutions. This role requires a strong technical leader who actively contributes to development while guiding a team of analysts and data...
