Associate Director, Statistical Programming

Role: Associate Director, Statistical Programming supporting global rare disease programs within Travere Therapeutics. Main objectives include providing strategic programming input, developing standards, overseeing project execution, and ensuring compliance for clinical trial analyses and submissions. Responsibilities encompass leading programming efforts, managing vendors, validating datasets, and preparing regulatory documentation such as SDTM, ADaM, and Define.xml files. Qualifications: Bachelor's in Statistics, Computer Science, or related field; at least 8 years' experience in clinical research with SAS programming, including 3-5 years in leadership roles; strong knowledge of CDISC standards, regulatory guidelines (ICH, FDA), and submission processes. Preferred: Master's degree, experience with UNIX, R, and vendor management. High-Value: Supporting phase I-IV trials in rare diseases, delivering clinical datasets and reports for regulatory submissions, with an emphasis on accuracy and efficiency. Work setup: Hybrid in San Diego, with face-to-face requirements; remote options limited.