Marie Gabrielle L.

Physician-Led Biostatistics, Clinical Trial Design, and Senior Medical Writing I am a board-certified Internal Medicine specialist (M.D., FPCP) with over 20 years of clinical experience, an MSc in Pharmacology, and specialized training in Biostatistics. I bridge the gap between high-level medical science and complex data analysis. What makes my approach unique? I provide the "Unicorn Advantage": the clinical insight of a practicing physician combined with the technical proficiency of a data scientist. I don't just analyze data; I understand the pathology, pharmacology, and patient reality behind the numbers. Core Areas of Expertise: Biostatistics & Data Science (R, SAS, Python) I specialize in providing biostatistical power for high-stakes clinical trials and academic research. Statistical Analysis Plans (SAP): Defining data handling, sample size calculations, and power analysis. Advanced Analytics: Expertise in R, SAS, and Python for interim and final study analyses. Meta-Analysis: Systematic reviews and data synthesis for Scopus/PubMed publication. Clinical Research & Trial Management As a former Principal Investigator for drug studies (including cardiology and PK-PD trials), I understand the "Lab-to-Launch" journey. Protocol Development: Designing scientifically sound study designs that pass Ethics Board (IRB/ERB) reviews. ICH-GCP Compliance: Ensuring all research meets international safety and ethical standards. Regulatory Support: Drafting technical dossiers for FDA notifications and USPTO/IPO patent submissions. Senior Medical Writing & Academic Mentorship I have authored two medical textbooks and numerous peer-reviewed manuscripts. Clinical Study Reports (CSR): Drafting comprehensive reports and Investigator Brochures. Journal Publication: Manuscript preparation, editing, and submission strategy for high-impact journals. Thesis Mentorship: Guiding MD, PhD, and Allied Health students through methodology, data analysis, and defense preparation. Regulatory & Digital Health Innovation With a background as a Cloud Architect and founder of a licensed pharmacy/clinic, I help health-tech startups navigate: Compliance: GDPR, HIPAA, and Philippine Data Privacy Act implementation. Product R&D: From laboratory formulation (cosmetics and anti-aging) to commercial stability testing. Why Hire a Physician-Biostatistician? Most biostatisticians are pure mathematicians; most medical writers are purely clinical. I offer both. Whether you are a pharmaceutical sponsor needing an ICH-GCP compliant protocol or a researcher struggling with "Chapter 4" data analysis, I provide the scientific foundation you need to achieve excellence. Let’s discuss your project goals—from data interpretation to publication.