Contract Statistical Programmer

Job Summary

Working remotely on a contract basis, the Contract Statistical Programmer will develop, validate, and maintain statistical programming deliverables for clinical studies and regulatory submissions while collaborating with cross-functional teams in a fast-paced biotech environment.

Key responsibilities

• Develop, validate, and maintain SAS and/or R programs for SDTM, ADaM datasets, and TLFs in accordance with CDISC standards
• Support statistical analyses for safety reports, regulatory submissions, and other ad hoc reporting needs
• Ensure compliance with FDA regulations, GxP, and internal SOPs while performing quality control of statistical programs and outputs

Required qualifications

• Master's degree in a quantitative field with 5+ years of relevant experience or a bachelor's degree with 8+ years of experience
• Strong proficiency in SAS and/or R for clinical trial data analysis and reporting
• Working knowledge of CDISC standards and regulatory submission requirements
• Experience producing TLFs and SDTM/analysis datasets in a pharmaceutical or biotechnology setting
• Familiarity with regulatory guidelines and GxP-compliant programming practices