Biostatistician / Epidemiologist

A company is looking for a Mid-level Biostatistician / Epidemiologist specializing in Real World Evidence (RWE), Regulatory and Life Sciences Research, to work remotely in the US.

Key Responsibilities

Lead statistical design, analysis, and reporting of regulatory studies integrating RWE

Develop statistical analysis plans (SAPs), table shells, and outputs aligned with regulatory expectations

Generate and QC regulatory-quality outputs, including RWE study reports and FDA submissions

Required Qualifications

MS or Doctoral degree in Biostatistics, Statistics, Epidemiology, or a related quantitative field

At least 7 years of experience in biostatistics / epidemiology using real-world data

Strong knowledge of real-world data sources and study design principles

Proficient in SAS programming, including macros and dataset manipulation

Experience preparing regulatory-grade documents is desired but not required