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
Experience: 5 years required