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

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.

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Job Tags

Full time, Interim role

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