Biostatistician

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

Salary Range $130000-$140000years TCS Employee Benefits Summary: Discretionary Annual Incentive. Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. Family Support: Maternal & Parental Leaves. Insurance Options: Auto & Home Insurance, Identity Theft Protection. Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement. Time Off: Vacation, Time Off, Sick Leave & Holidays. Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing. #LI-SP1