Responsibilities include:

• Conducted mixed-effects modeling and pharmacokinetic/pharmacodynamic (PK/PD) analyses for complex study designs across cardiovascular and topical products.

• Developed simulation-based adaptive sample size estimations using survival analysis, improving trial efficiency and reducing study timelines.

• Led statistical reanalyses for bioequivalence and drug-drug interaction studies, aligning outputs with evolving regulatory expectations.

• Provided statistical input for Scientific Advice Procedures and product development strategy, contributing to regulatory dossier quality.

• Authored Clinical Development Plans and methodological justifications for clinical trials and product registration strategies.

• Collaborated with cross-functional teams including regulatory affairs and clinical operations to align statistical deliverables with project milestones and dossier timelines.

Responsibilities include:

• Served as Lead Statistician for 5+ adaptive clinical trials, specializing in mixed-effects modeling, simulation-based sample size calculations, and longitudinal analyses.

• Provided strategic statistical guidance on regulatory interactions (EMA, FDA), Scientific Advice Procedures, and post-authorization safety studies (PASS).

• Developed comprehensive Statistical Analysis Plans (SAPs), Clinical Study Reports (CSRs), and regulatory-compliant statistical programming outputs.

• Conducted signal detection and safety data reviews to reinforce pharmacovigilance strategies and support robust regulatory submissions.