Yogita Kolekar Thoke

Senior Biostatistician, Fsp-bms @Parexel

Hyderabad, IN

Expertise in designing and executing end-to-end clinical trials with a strong foundation in biostatistics. Proficient in Phase II, and IV of trial development, with hands-on experience in study concept sheet, study design, sample size estimation, statistical analysis planning, protocol development, Tables, Listings, and Figures (TLFs) generation and review, eCRF design input and review, data analysis, clinical study reports (CSR) and interpretation of results. Strong commitment to regulatory compliance and industry best practices. Successfully collaborated with cross-functional teams to ensure timely and high-quality delivery of statistical deliverables, including datasets, analysis outputs, and Clinical Study Reports (CSRs). Contributed to regulatory submissions by preparing statistical summaries, justifications, and regulatory-compliant documentation for clinical trial data. Manuscript development and publication activities, including statistical input, result interpretation, and responding to reviewer comments. Worked on manuscript preparation and peer-reviewed publications in collaboration with medical writers and clinical teams Mentored junior statisticians, providing guidance on statistical methodologies and clinical trial analysis. Ensured data integrity and accuracy by implementing robust quality control procedures throughout the statistical analysis process. Software proficiency: SAS and nQuery.