Sr. Statistical Programmer

SimulStat Incorporated; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

SimulStat Incorporated is seeking a Senior Statistical Programmer to support the development, validation, and maintenance of statistical programming deliverables in line with CDISC standards. You will review data, create ADaM specifications, and contribute to study-level deliverables to meet timelines and quality expectations.

Applicants should have at least 6 years of experience in statistical programming within a clinical or regulated environment and hold a Bachelor’s or Master’s degree in a

Qualifications

• Bachelor’s or Master’s degree in a relevant field or equivalent experience.
• At least 6 years of experience in statistical programming in a clinical or regulated environment.

Responsibilities

• Support development, validation, and maintenance of statistical programming deliverables (analysis datasets, tables, listings, figures) aligned with CDISC standards.
• Perform data review and validation to ensure accuracy, consistency, and integrity of analysis results.
• Create ADaM or ADaM-like programming specifications from analysis definitions or SAP.
• Contribute to study-level deliverables, ensuring timelines and quality.
• Participate in submission-related activities, including preparation and review of supporting documentation and validation outputs.
• Assist with continuous improvement of programming processes, standards, and efficiencies.

Skills

Statistical programming

Data review

Documentation

Education

Bachelor’s or Master’s degree in a relevant field

Job description

Key Responsibilities

• Support the development, validation, and maintenance of statistical programming deliverables, including analysis datasets and reporting outputs (tables, listings, and figures) aligned with CDISC standards
• Perform data review and validation activities to ensure accuracy, consistency, and integrity of analysis results
• Create ADaM or ADaM-like programming specifications based on analysis definitions or SAP.
• Contribute to study-level deliverables, ensuring timelines and quality expectations are met
• Participate in submission-related activities, including preparation and review of supporting documentation and validation outputs
• Assist with continuous improvement efforts related to programming processes, standards, and efficiencies

Qualifications

• Bachelor’s or Master’s degree in a relevant field or equivalent experience
• Min. of 6 years of experience in statistical programming within a clinical or regulated environment