Overview:
With over 11 years of experience in SAS Clinical Programming, I have contributed to multiple high-impact clinical trials across various therapeutic areas. Below is a snapshot of some of my recent projects, highlighting my roles and expertise:
Recent Projects
1. Phase 3 Study: MRTX949 vs. Docetaxel in NSCLC with KRAS G12C Mutation
- Therapeutic Area: Oncology
- Role: Senior SAS Programmer
- MOA: MRTX949 is a selective KRAS G12C inhibitor that blocks tumor cell proliferation.
- Summary: Worked extensively on SDTM and ADaM datasets, creating TLFs and ensuring data integrity for regulatory submissions.
2. Phase 1b Open-label Study: Active Drug + Anticancer Therapy in Advanced/Metastatic Solid Tumors
- Therapeutic Area: Oncology
- Role: Senior SAS Programmer
- MOA: The active drug modulates the immune response to enhance the effect of anticancer therapy.
- Summary: Involved in data mapping, validation, and QC of clinical data, contributing to interim analysis and reporting.
3. Phase 1 Trial: Intralesional Immunotherapy with Active Drug Vaccine in Merkel Cell and Cutaneous Squamous Cell Carcinoma
- Therapeutic Area: Oncology
- Role: STAT-2 Programmer
- MOA: The vaccine stimulates an immune response against tumor-specific antigens.
- Summary: Focused on generating complex datasets, programming ADaM datasets, and preparing statistical outputs.
4. Phase 2 Multicenter Study: Enzastaurin in Relapsed Cutaneous T-cell Lymphoma
- Therapeutic Area: Oncology
- Role: STAT-2 Programmer
- MOA: Enzastaurin inhibits PKC-β, preventing tumor growth and angiogenesis.
- Summary: Played a key role in developing and validating CDISC-compliant datasets and supporting statistical analysis.
5. Phase 3 RCT: Efficacy and Safety of Pembrolizumab vs. Placebo in Advanced NSCLC
- Therapeutic Area: Oncology
- Role: STAT-2 Programmer
- MOA: Pembrolizumab is a PD-1 inhibitor that restores immune system response to tumor cells.
- Summary: Delivered TLFs and performed data checks for efficacy and safety analysis.
6. Bioequivalence Study: Solifenacin Succinate Tablets in Healthy Adults
- Therapeutic Area: Neurology
- Role: Junior Programmer
- MOA: Solifenacin is a muscarinic receptor antagonist that reduces bladder overactivity.
- Summary: Assisted in generating clinical datasets and conducting bioequivalence analysis.