Clinical Statistical Programmer - III (Senior)

Location: Remote

About the role

Provide expert-level statistical programming support for clinical and device studies, CSRs, ISS, client summaries, and exploratory analyses.

Responsibilities

• Develop, validate, and maintain SAS programs, macros, and programming templates.
• Generate and QC SDTM/ADaM datasets and Tables, Listings, and Figures (TLFs).
• Review and approve SDTM/ADaM data specifications and submission-ready datasets.
• Perform rigorous QC of statistical programming deliverables for regulatory compliance.
• Support FDA submissions, publications, and other clinical data programming activities.
• Apply CDISC standards, departmental SOPs, and regulatory requirements to programming deliverables.
• Develop innovative programming strategies and automation solutions.

Requirements

Education: Bachelor’s or Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related quantitative discipline.

• 10+ years of hands-on statistical programming experience within pharmaceutical, biotech, or CRO environments.
• Expert-level SAS programming and SAS macro development.
• Advanced experience with CDISC SDTM and ADaM standards.
• Hands-on experience developing TLFs (Tables, Listings, and Figures).
• Experience developing and validating submission-ready clinical datasets.
• Experience with Define.xml and SDTM/ADaM data specifications.
• Hands-on experience supporting clinical and device studies.
• Experience with programming QC/validation and review of statistical programming deliverables.
• Knowledge of GCP/ICH guidelines and FDA regulatory requirements.

Qualifications

• Experience supporting NDA, MAA, or BLA regulatory submissions.
• Programming experience with R or Python for statistical analysis or automation.
• Experience developing reusable departmental macros, templates, and automation tools.
• Experience supporting clinical publications and publication-related programming requests.

Pay

Pay Rate: $90/hour W2 • Duration: 3 months