Shubham Thakare

Biostatistician @Tata Consultancy Services

Mumbai, IN

Working as a biostatistician on foundational studies, providing statistical oversight and actively participating in project meetings to ensure alignment with study objectives. Prepared Statistical Analysis Plans (SAPs), including mock TFLs.• Perform statistical analysis to ensure acceptable and desired quality profile of the product irrespective of having change in manufacturing process, analytical methods, testing laboratories or storage conditions of the study drug with accuracy, develop or modify existing SAS programs to generate desired statistical output.• Evaluate data structure and problem scenario to understand the objective of the analysis. Based on that fit an appropriate statistical model (ANOVA, ANCOVA, Regression, Linear Mixed Effect Model etc) which fits the data in the closest manner. Also evaluate the accuracy of the fitted model by looking into different fit statistics.• Perform power calculation to evaluate sample size, testing of hypothesis, confidence interval estimation based on product quality data and conclude statistically.• Provided support in developing ad hoc reports as needed, tailoring outputs to meet specific project or stakeholder requirements.• Maintained the quality and timeliness of programming-related deliverables, consistently meeting project deadlines.• Regularly updated project documentation, ensuring that all records were current and accurately reflected the status of programming activities. Working on different SAS procedure.• Perform approvals/rejections/reviews of workflows (Review/Approval) via client ’s document management system. Coordinating with the client and US team for clarity of specifications, data issues, outliers, reviews, schedules, etc.

Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon

Bsc

MIT World Peace University

Msc