Remote Principal Statistical Programmer

CareersElite.com; New Year (MT); On-site; USD 130,000 - 207,000; Full time

Job summary

CareersElite.com is seeking an experienced Principal Statistical Programmer to provide hands-on SAS programming support for clinical studies. You will develop and validate analysis datasets, tables, listings and figures for regulatory submissions and internal presentations, while maintaining regulatory-compliant documentation.

The role requires strong SAS skills, CDISC SDTM/ADaM experience, and collaboration with Biostatistics and CDM.

Qualifications

• Bachelor's degree in Statistics, Mathematics, Computer Science or related STEM with 5+ years of statistical programming experience OR
• Master’s degree with 3+ years of statistical programming experience
• Experience in clinical trials environment (pharmaceutical or medical device)
• Strong SAS programming experience for clinical trial data (Base/STAT/Macros)
• Experience developing/validating analysis datasets, tables, listings, figures
• Regulatory requirements (GCP/ICH/FDA/ISO) and CDISC standards (SDTM/ADaM)
• Experience delivering inspection-ready programming deliverables
• Interfacing SAS outputs with Excel/Word/PowerPoint

Responsibilities

• Develop analysis datasets, specs, and outputs for study reports and regulatory submissions.
• Create, modify, and maintain SAS programs meeting regulatory standards for reporting and traceability.
• Perform independent program review and validation with proper documentation.
• Support ad hoc analyses with the statistician and data review questions.
• Collaborate with CDM and Biostatistics to review CRFs, specs, edits, and derivations.
• Identify programming risks or data issues and communicate them to the study team.

Skills

SAS programming

Clinical trials experience

Regulatory knowledge (GCP/ICH/FDA)

CDISC SDTM/ADaM

Data management collaboration

Problem solving

Education

Bachelor's degree in Statistics/Mathematics/CS or related STEM

Master’s degree in related STEM field

Tools

SAS Macros

Excel/Office interoperability

R or Python (preferred)

Job description

CareersElite.com is seeking an experienced Principal Statistical Programmer to provide hands-on SAS programming support for clinical studies. You will develop and validate analysis datasets, tables, listings and figures for regulatory submissions and internal presentations, while maintaining regulatory-compliant documentation.

The role requires strong SAS skills, CDISC SDTM/ADaM experience, and collaboration with Biostatistics and CDM.