Biostatistical Analyst for Regulatory & IVD Data

Streck, Inc.; La Vista (NE); On-site; USD 85,000 - 110,000; Full time

Job summary

Sretch, Inc. in Nebraska is seeking a Biostatistical Analyst to apply statistical methods to support clinical research, assay development, and regulatory submissions for IVD devices.

You will collaborate with R&D, Regulatory, and Quality teams to translate complex study data into clear findings. The role requires a Master’s in Biostatistics or related field, 2+ years of design, analysis, and reporting experience, and strong skills in R, SAS, or Python.

Qualifications

• Master's degree required.
• Experience designing, analyzing, and reporting.
• Strong written and verbal communication skills.

Responsibilities

• Analyze analytical and clinical studies of IVD devices for regulatory submissions.
• Support technical writing for documentation related to internal audits.
• Write reports and technical documents summarizing project findings.
• Prepare protocols, abstracts, and manuscripts; assist with responses to statistical questions from regulators and health authorities.
• Address statistical issues arising in regulatory, quality, compliance or legal settings.
• Provide statistical training for non-statistical colleagues in R&D and Quality Control.
• Participate in department, division, and team meetings and client/trade conference meetings as needed.
• Stay current on developments in statistics, diagnostics, and regulatory guidance.

Skills

R

SAS

Python

Written and verbal communication

Education

Master's degree in Biostatistics or related field

Tools

SAS/Base

SAS Macro

R

Minitab

Job description

Sretch, Inc. in Nebraska is seeking a Biostatistical Analyst to apply statistical methods to support clinical research, assay development, and regulatory submissions for IVD devices.

You will collaborate with R&D, Regulatory, and Quality teams to translate complex study data into clear findings. The role requires a Master’s in Biostatistics or related field, 2+ years of design, analysis, and reporting experience, and strong skills in R, SAS, or Python.