Job
Description
This role supports the generation of evidence from patient-reported outcomes across multiple therapeutic areas, with a strong emphasis on oncology. The ideal candidate will have hands-on experience with clinical trial data, deep familiarity with PRO instruments, and strong SAS programming skills. Knowledge of CDARS and experience working in a global, cross-functional environment are essential. Key Responsibilities Develop, validate, and maintain SAS programs for PRO data analysis, including derivation of endpoints, generation of TLFs, and QC of outputs Collaborate with statisticians, study leads, and cross-functional teams to interpret protocols and SAPs, define specifications, and deliver high-quality outputs Support the development and maintenance of standard templates and macros for common PRO instruments (e.g., EQ-5D, EORTC QLQ-C30, FACT-G) Participate in the creation and refinement of guidance documents, SOPs, and training materials for PRO programming workflows Ensure compliance with internal quality standards and regulatory expectations, including documentation of programming logic and QC processes Engage in biweekly PRO team meetings to share updates, troubleshoot issues, and align on priorities Required Qualifications Bachelor’s or Master’s degree in Statistics, Biostatistics, Computer Science, or a related field 3–5 years of experience in statistical programming with a focus on clinical trial data and PRO endpoints Proficiency in SAS; working knowledge of R is a plus Strong understanding of CDARS and familiarity with CDISC standards Experience with multiple therapeutic areas; oncology experience is highly preferred Ability to work independently and collaboratively across time zones in a multicultural environment Preferred Qualifications Familiarity with regulatory guidance on PROs and clinical outcome assessments Experience with automation tools and version control systems (e.g., Git) Exposure to project management tools like Monday.com #LI-REMOTE
