Contract Statistical Programmer

Responsibilities:

• Develop, validate, and maintain SAS and/or R programs for SDTM, ADaM datasets, and TLFs.
• Support statistical analyses for safety reports, publications, and regulatory submissions.
• Ensure compliance with FDA 21 CFR Part 11, GxP, and internal SOPs.

Qualifications:

• Master's degree in a quantitative field with 5+ years experience, or bachelor's with 8+ years.
• Strong proficiency in SAS and/or R for clinical trial data analysis.
• Working knowledge of CDISC standards and regulatory submission requirements.

Work Environment:

• This role operates in a professional office or remote work environment.
• Employees are expected to maintain a safe, distraction-free workspace.
• Remote collaboration with biostatisticians, data managers, and clinical teams.