Madhukar Gawade
Senior Biostatistician @ Cytel | Vaccine Studies | Clinical Trials | SAP | TLF | SAS & R | Data Science & Meta-analysis
- Role
- Senior Biostatistician at Cytel Statistical Software & Services Private Limited
- Location
- Kolhapur, MH, IN
- LinkedIn followers
- 500 followers
About Madhukar Gawade
Biostatistician with 7+ years of experience in clinical research, specializing in vaccine studies, statistical modeling, and clinical trial analytics. Currently working as a Senior Biostatistician, leading statistical activities across study design, protocol development, and analysis for global clinical trials.Expertise includes Statistical Analysis Plan (SAP) development, sample size estimation, randomization, TLF generation, and end-to-end statistical support for clinical and cosmetic studies. Strong experience working in cross-functional teams and contributing to key trial milestones including FSFV readiness, risk-based monitoring, and safety reviews.Proficient in SAS, R, Python, and CDISC standards (SDTM & ADaM), with hands-on experience in advanced statistical methods, meta-analysis, and machine learning techniques. Developed multiple automation tools using R Shiny, Power BI, and Python to enhance efficiency in data analysis and reporting.Passionate about leveraging data-driven insights to improve clinical decision-making and contribute to innovative healthcare solutions.
Experience
Senior Biostatistician
Cytel Statistical Software & Services Private Limited
Jan 2024 — Present · IN
Lead study statistician for vaccine clinical trialsProvide statistical input for study protocols and designDevelop Statistical Analysis Plans (SAPs)Perform QC of TLFs and ensure data integritySupport pre-FSFV activities including QTL, RBM, UAT, and CRF development
Education
Kolhapur Jobs
Master's degree, Statistics
2015 — 2017
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