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.
Qualifications:
BACHELOR OF COMPUTER SCIENCE