• Lead SAS and R programming for Oncology and HIV studies, including compound-level submissions.

• Drive R-based workflows (admiral, R4QC) for ADaM and TLF production and QC.

• Develop advanced SAS macros and automation frameworks to streamline SDTM/ADaM and TLF processes.

• Manage study timelines, resources, and Agile/Jira workflows across multiple projects.

• Collaborate with statisticians, data management, and cross-functional teams to deliver high-quality, submission-ready outputs.

• Prepare eCRT components including define.xml, annotated CRFs, and reviewer’s guides.

• Programmed and validated SDTM, ADaM, and TLFs for multiple Oncology trials.

• Supported CSRs, interim analyses, and regulatory deliverables.

• Conducted QC using PROC COMPARE, PROC FREQ, PROC MEANS, and independent validation.

• Collaborated on CRF reviews, SAP interpretation, and TLF shell development.

• Managed programming priorities across multiple studies while ensuring GCP and SOP compliance.

• Primary programmer for multiple Phase II/III studies and ISS/ISE submissions.

• Developed and validated ADaM datasets, pooled datasets, and TLFs per SAP.

• Produced ad-hoc analyses and FDA response outputs.

• Performed ETL and SDTM mapping using SAS DATA steps and PROC SQL.