Biostatistical Analyst - Regulatory & IVD Analytics

Streck, LLC; La Vista (NE); On-site; USD 85,000 - 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

On and off campus career development

Job summary

Streck, a Nebraska-based manufacturing company, seeks a Biostatistical Analyst to apply statistics to clinical research and regulatory submissions for IVD devices. You will collaborate with R&D, Regulatory, Quality Control, and Strategic Accounts to translate study data into actionable findings.

The role emphasizes quality communication, teamwork across disciplines, and staying current with industry guidance and standards.

Qualifications

• Master's degree in Biostatistics, Statistics, or related field.
• 2+ years designing, analyzing, and reporting statistics.
• Proficiency with R, SAS, and/or Python.
• Excellent written and verbal communication; ability to explain complex stats to a general audience.

Responsibilities

• Analyze and interpret analytical and clinical studies of IVD devices for regulatory submissions (FDA).
• Support technical writing for documentation relevant to internal audits.
• Write reports and technical documents summarizing project findings.
• Prepare protocols, abstracts, and manuscripts; respond to statistical questions from regulators and IRBs.
• Address statistical issues in regulatory, quality, compliance, or other settings.
• Provide statistical training for non-statistical colleagues in R&D and Quality Control.
• Participate in meetings, client events, conferences, and industry gatherings as needed.
• Stay current on statistics, diagnostics industry, and regulatory guidance.

Skills

R SAS Python proficiency

Written & verbal communication

Interdisciplinary collaboration

Explain statistics clearly

Education

Master's degree in Biostatistics/Statistics

Tools

SAS/Base

SAS Macro

R

Minitab

Job description

Streck, a Nebraska-based manufacturing company, seeks a Biostatistical Analyst to apply statistics to clinical research and regulatory submissions for IVD devices. You will collaborate with R&D, Regulatory, Quality Control, and Strategic Accounts to translate study data into actionable findings.

The role emphasizes quality communication, teamwork across disciplines, and staying current with industry guidance and standards.