Clinical Study Design & Data Management
End-to-end support from protocol development and eCRF design to database lock. I manage clinical data using EDC systems (REDCap, MaganaMed), oversee data monitoring and query resolution, and structure datasets to CDISC standards (SDTM/ADaM) — fully compliant with ICH E6(R2) GCP and 21 CFR Part 11. I also support trial design optimisation and patient stratification strategies to accelerate safe and effective therapy development.
Statistical Analysis & Biostatistics
Rigorous statistical analysis of clinical datasets, from hypothesis testing and power analysis to longitudinal, survival, and mixed-effects models. I develop machine learning models to identify disease risk, stratify patients, and uncover patterns in complex biomedical datasets that support precision medicine. I produce Tables, Figures, and Listings (TFLs) for regulatory submissions, and translate results into clear, decision-ready outputs through interactive dashboards and data visualisations.
Multi-omics Data Analysis
I integrate genomics, transcriptomics, proteomics, and metabolomics data to reveal the molecular drivers of disease and identify potential therapeutic targets. By combining multiple layers of biological information, I build a systems-level understanding of complex phenotypes — supporting biomarker discovery, patient stratification, and the translation of molecular findings into actionable clinical insights.
Regulatory Medical Writing
Authoring and reviewing regulatory documents for pharmaceutical, biotech, and medical device companies — including Clinical Investigation Plans (CIP), Clinical Investigation Reports (CIR), interim reports, periodic safety reports, and clinical study synopses. All deliverables are aligned with ICH, FDA, EMA, and MDR requirements.
Scientific Writing & Publications
Expert preparation of peer-reviewed manuscripts, systematic reviews, meta-analyses, scoping reviews, and consensus documents. With 30+ publications across cardiology, neuroscience, and molecular biology, I bring scientific rigour and clarity to every manuscript — from first draft to journal submission.
Scientific Consulting
Independent scientific advice for research teams, CROs, and industry partners. I support study strategy, critical appraisal of biomedical evidence, data anonymization and privacy compliance (GDPR, HIPAA, EMA Policy 0070), and provide domain expertise across cardiovascular biology, neurophysiology, and oncology.
Mathematical Modeling & Network Analysis
Computational modeling of complex biological systems, with deep expertise in cardiac electrophysiology — including action potential propagation, reentry, and arrhythmia substrates using openCARP. I model ion channel dynamics (Hodgkin–Huxley, Markov-state formalism) and synaptic and neuronal network behaviour. I also construct and analyse biological interaction networks to uncover key regulatory pathways and molecular hubs involved in disease progression and drug response.