Biostatistician

Job Description

Must Have Technical/Functional Skill. Good in statistical methodologies, SAS, Regulatory Standards.

• 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.

Bachelor of Computer Science.

$130000-$140000 per year.