Q#2 Can you share your recent 6 study titles, therapeutic areas, and roles?

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.