Senior Statistical Programmer - Regulatory Submissions

Jobtailor; California (MO); On-site; USD 85,000 - 125,000; Full time

Job summary

Jobtailor is seeking a skilled Statistical Programmer to join our clinical data programming team. You will ensure the integrity of programming solutions, generate outputs for trials, and support regulatory submissions, publications, and promotions.

You will maintain validated programs and assist with ad hoc analyses across multiple projects. The role requires strong knowledge of R or SAS, 3+ years of experience, and a bachelor’s degree in statistics, computer science, or life sciences.

Qualifications

• Ability to program, document, and validate statistical software code in R or SAS.
• 3+ years of relevant programming experience with a Bachelor’s degree in a related field, or 1+ year with a Master’s degree.
• Bachelor’s degree or equivalent in Statistics, Computer Science, Life Sciences, or related field.
• Experience with regulatory submissions/regulatory guidelines (GCP, ICH).
• Demonstrated competence in statistical programming for clinical trials.

Responsibilities

• Ensure integrity of programming solutions for assigned projects.
• Lead production output generation for statistical reports, CSR, and regulatory submissions; support publications and market promotions.
• Create datasets, tables, figures, and listings for trials and submissions; assist ad hoc analyses.
• Provide programming support for supplemental analyses and internal/external requests.
• Maintain program libraries; ensure QC compliance and documentation archiving.
• Ensure audit readiness of programming deliverables; identify improvement opportunities.
• Collaborate cross-functionally and lead ad hoc teams when needed.

Skills

Statistical Programming

Experience in Programming

Data Analysis

Communication Skills

Education

Bachelor’s degree in Statistics, Computer Science, or Life Sciences

Tools

R

SAS

Job description

Jobtailor is seeking a skilled Statistical Programmer to join our clinical data programming team. You will ensure the integrity of programming solutions, generate outputs for trials, and support regulatory submissions, publications, and promotions.

You will maintain validated programs and assist with ad hoc analyses across multiple projects. The role requires strong knowledge of R or SAS, 3+ years of experience, and a bachelor’s degree in statistics, computer science, or life sciences.