Biostatistical Analyst – Regulatory Submissions & Insights

Streck; La Vista (NE); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

No night or weekend shifts

Excellent work life balance

Market competitive pay

Comprehensive benefits

Great team environment

Career development opportunities

Job summary

Streck, a Nebraska-based manufacturing company, seeks a Biostatistical Analyst to apply statistical methods to support clinical research, assay development, and IVD device submissions. You will work closely with R&D, Regulatory, Quality Control, and Strategic Accounts to turn complex study data into clear findings for regulatory submissions.

Requirements include a Master’s degree in Biostatistics or related field and at least 2 years of relevant experience, with strong skills in R, SAS, and

Qualifications

• Master's degree required in Biostatistics, Statistics, or related field.
• 2+ years designing, analyzing, and reporting.
• Strong fluency with R, SAS, and/or Python.

Responsibilities

• Analyze analytical and clinical studies of IVD devices for regulatory submissions.
• Write reports and technical documents summarizing project findings.
• Provide statistical training for non-statistical colleagues in R&D and Quality Control.

Skills

R

SAS

Python

Education

Master's degree in Biostatistics, Statistics, or a related field

Tools

SAS/Base

SAS Macro

R

Minitab

Job description

Streck, a Nebraska-based manufacturing company, seeks a Biostatistical Analyst to apply statistical methods to support clinical research, assay development, and IVD device submissions. You will work closely with R&D, Regulatory, Quality Control, and Strategic Accounts to turn complex study data into clear findings for regulatory submissions.

Requirements include a Master’s degree in Biostatistics or related field and at least 2 years of relevant experience, with strong skills in R, SAS, and