Biostatistician

Job Description Must Have Technical/Functional Skill. Good in statistical methodologies, SAS, Regulatory Standards. Roles & Responsibilities Designing and powering clinical and observational studies, defining endpoints, and developing statistical analysis plans. Validation programming to produce reproducible analysis datasets and TFLs. Performing primary, supportive, interim and post market analyses. Simulations for complex or adaptive designs. Preparing regulatory grade statistical reports and responding to agency questions. Supporting real world evidence generation. Specify primary/secondary endpoints, success criteria, performance goals, and equivalence/non inferiority margins for clinical trials. Calculation of sample sizes and power, and provide simulations for complex designs (adaptive, group sequential, Bayesian), randomization schemes, stratification, and blinding feasibility. Creating detailed Statistical Analysis Plans (SAPs) and addenda (including interim and adaptive analysis plans). Draft statistical sections for regulatory submissions and responses to regulator questions. Run simulations for adaptive designs. Plan and implement interim analyses and stopping rules for DSMB & adaptive trials. Provide independent statistical support or serve as statistician for Data Safety Monitoring Boards. Implementation of alpha spending and multiplicity control methods for adaptive designs. Produce statistical reports, statistical sections of Clinical Study Reports (CSRs), and submission-ready tables/figures/listings. Design and analyze post market surveillance studies, registries, and post market clinical follow up (PMCF) for post marketing and RWE studies. Qualifications Bachelor of Computer Science. Salary Range $130000-$140000 per year. #J-18808-Ljbffr Tata Consultancy Services Limited