- Manages multiple studies within the Lung/ Head & Neck Indications of an immune-oncology statistical programming team- Programs in-house deliverables as both lead and validation programmer for CSRs, DMCs, SDRPs, Event-Based Requests, Protocol Deviations, etc. using SAS (Macros, Graph, Data Steps, and appropriate Procs) and SQL- Ensures quality of vendor deliverables for study CSR, SDRP, DMC, etc. through programmatic and regulatory requirement checks following established protocols and standards- Reviews study documents and templates including Statistical Analysis Plans, SDTM Data Specifications, ADaM Specifications, and Data Presentation Plans and provides constructive feedback to both study team and vendor partners- Develops Core ADaM standards for trial endpoints such as PFS2 as a member of the Efficacy Standards Subteam- Reviews electronic submission deliverables for regulatory application submissions- Handles data transfers to and from vendor partners- Proficiently operates within UNIX environment

• Collaborate on both clinical research projects and quality initiative projects with investigators in the Duke University Department of Neurology and the Duke University Transplant Center.• Write detailed Statistical Analysis Plans (SAPs), perform analyses using SAS and/or R, generate reproducible output for statistical reports, and edits abstracts and manuscripts with minimal to no supervision.• Proactively and efficiently manage timelines for multiple projects across collaborations with competing deadlines to meet all deliverable deadlines.• Lead meetings with investigators to gather background information and translate clinical goals into testable statistical hypotheses given the available data.• Explain complex statistical methodologies, verbally and written, in a digestible manner to investigators and other collaborators with minimal to no statistical training.