Senior Statistical Programmer - Clinical SAS, SDTM & ADaM 3672885
Axiom Path
Job Description
Job Description
Be Part Of A High-Performing Team
Join a clinical development environment focused on producing high-quality statistical programming deliverables that support clinical studies, regulatory submissions, publications, and data-driven decision-making. This role works closely with cross-functional stakeholders and requires a programmer who can independently manage complex assignments while maintaining rigorous quality and CDISC compliance.
What's In Store For You
- Opportunity to support clinical studies and regulatory submission activities.
- Exposure to both production and validation of key clinical programming deliverables.
- Work across SDTM, ADaM, tables, figures, listings, and exploratory analyses.
- Collaborate with statistical, clinical, and other cross-functional stakeholders.
- Apply both SAS and R programming expertise across multiple concurrent projects.
How You Will Make An Impact
- Provide statistical programming support for clinical studies and submission-related deliverables.
- Develop and validate CDISC-compliant SDTM and ADaM datasets.
- Create and maintain programs supporting ad-hoc, exploratory, publication, and other analytical needs.
- Develop and validate tables, figures, and listings for clinical analyses.
- Create dataset specifications aligned with SDTM Implementation Guides, ADaM Implementation Guides, and Statistical Analysis Plans.
- Develop, maintain, troubleshoot, and apply SAS macros and reusable utility programs.
- Design, develop, and test programming solutions for complex clinical and business requirements.
- Independently manage multiple assignments while delivering accurate, high-quality work within project deadlines.
- Partner effectively with cross-functional teams and stakeholders throughout study execution.
Do you bring proven success in clinical statistical programming and CDISC standards?
- Bachelor's degree in Mathematics, Statistics, Computer Science, or a related discipline.
- Professional experience within pharmaceutical, biotechnology, or a closely related clinical research environment; pharmaceutical or biotechnology experience is preferred.
- Advanced SAS programming skills and a strong statistical programming foundation.
- Solid hands-on R programming experience.
- Demonstrated experience with CDISC standards, including both SDTM and ADaM.
- Experience creating and validating clinical analysis datasets and associated programming deliverables.
- Ability to interpret and work from SDTM IG, ADaM IG, and Statistical Analysis Plans.
- Strong understanding of SAS macros and reusable programming utilities.
- Regulatory submission programming experience is highly desirable.
- Experience with additional technologies such as Python, VBA, or C++ is helpful.
- Strong written and verbal communication skills.
- Ability to work independently, collaborate across functions, manage competing priorities, and consistently meet deadlines with high-quality output.
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