Associate Director, Statistical Programming
Scorpion Therapeutics
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
- leading programming efforts
- managing vendors
- validating datasets
- 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
- 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
Vacancy posted 4 days ago
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