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