Senior Principal Statistical Programmer

Job Summary

Seeking a full-time Senior Principal Statistical Programmer to work remotely, this role will manage statistical programming activities for clinical trials, ensuring compliance with regulatory standards and collaborating with cross-functional teams.

Key Responsibilities

• Lead the design, development, validation, and maintenance of SAS programs for generating SDTM, ADaM, and TLFs
• Ensure compliance with CDISC standards and regulatory guidelines while performing quality control and peer review of deliverables
• Act as a technical subject matter expert, mentoring junior programmers and supporting regulatory submissions

Required Qualifications

• Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field
• Minimum of 10 years of experience in statistical programming within the pharmaceutical, biotechnology, or CRO industry, with oncology experience preferred
• Proficiency in SAS/Base, SAS/Macro, SAS/SQL, and SAS/Graph; familiarity with Python is preferred
• Strong experience with CDISC standards (SDTM and ADaM) and familiarity with define.xml and Pinnacle 21
• Experience supporting regulatory submissions to FDA and/or EMA