Statistical Programmer

SimulStat Incorporated; United States; Remote; USD 110,000 - 140,000; Full time

Job summary

SimulStat Incorporated in the United States is seeking a Senior Statistical Programmer to support the development, validation, and maintenance of analysis datasets and reporting outputs aligned with CDISC standards.

Responsibilities include data review for accuracy, creating ADaM-like specifications, contributing to study deliverables, supporting submissions, and driving continuous improvements in programming processes.

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.

Responsibilities

• Support the development, validation, and maintenance of statistical programming deliverables, including analysis datasets and reporting outputs 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.

Skills

CDISC standards

Statistical programming

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