Streck

Clinical laboratory products for accurate diagnostics

Biostatistical Analyst

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours

Full-timeLa Vista, NE, USANo salary listedIn-person

About the Job

Requirements

A master's degree in Biostatistics, Statistics, or a related field is required.
At least 2 years of experience directly related to designing, analyzing, and reporting is required.
Strong fluency with R, SAS, and/or Python is required.
Strong written and verbal communication skills are required.
Ability to work with scientists and stakeholders across disciplines is required.
Ability to explain complex statistical concepts in terms a general audience can follow is required.

Responsibilities

Analyze and interpret analytical and clinical studies of in vitro diagnostic devices for submissions to regulatory bodies such as the FDA.
Support technical writing for documentation relevant to internal audits.
Write reports and technical documents that summarize project findings.
Prepare protocols, scientific abstracts, and peer-reviewed manuscripts, and help develop responses to statistical questions from regulatory agencies, Institutional Review Boards, and other health authorities.
Address statistical issues that arise in regulatory, quality, compliance, or other legal settings.
Provide statistical training for non-statistical colleagues in R&D and Quality Control.
Take part in department, division, and team meetings, and join client meetings, trade shows, scientific conferences, and industry events as needed.
Stay current on developments in statistics, the diagnostics industry, and regulatory guidance through literature review, workshops, and professional meetings.

Desired Qualifications

Proficiency with SAS/Base, SAS Macro, R, or Minitab.
Familiarity with general clinical laboratory operations and procedures.
Basic knowledge of FDA Design Control and Quality System Regulation requirements.
Basic knowledge of FDA and EU submission processes and guidelines for in vitro diagnostic and In Vitro Diagnostic Regulation submissions.
Basic knowledge of Clinical and Laboratory Standards Institute guidelines, FDA guidance documents, and International Organization for Standardization documents.
Ability to design experiments that test a clear, concise hypothesis.

About Streck: Streck is a Nebraska-based manufacturing company that makes a global impact by developing and distributing to labs worldwide. Our products provide confidence for accurate health care testing! Our passions and priorities are focused on taking care of our customers, employees, and giving back to our community. Streck has jobs for every stage of your career. If you are a dependable, hard-working, and team-oriented individual who values meaningful work, Streck is looking for you to join our community of passionate people on a mission!

As a Biostatistical Analyst, you will apply statistical methods to support clinical research, new assay methods, and the design, validation, development, and delivery of in vitro diagnostic (IVD) devices. You will work closely with R&D, Regulatory, Quality Control, and Strategic Accounts, and you will help turn complex study data into clear findings that support regulatory submissions.

What you'll do

Analyze and interpret analytical and clinical studies of IVD devices for submissions to regulatory bodies such as the FDA
Support technical writing for documentation relevant to internal audits
Write reports and technical documents that summarize project findings
Prepare protocols, scientific abstracts, and peer-reviewed manuscripts, and help develop responses to statistical questions from regulatory agencies, Institutional Review Boards, and other health authorities
Address statistical issues that arise in regulatory, quality, compliance, or other legal settings
Provide statistical training for non-statistical colleagues in R&D and Quality Control
Take part in department, division, and team meetings, and join client meetings, trade shows, scientific conferences, and industry events as needed
Stay current on developments in statistics, the diagnostics industry, and regulatory guidance through literature review, workshops, and professional meetings

What you'll bring

Master's degree in Biostatistics, Statistics, or a related field
At least 2 years of experience directly related to designing, analyzing, and reporting
Strong fluency with R, SAS, and/or Python
Excellent written and verbal communication skills
Strong ability to work with scientists and stakeholders across disciplines
Ability to explain complex statistical concepts in terms a general audience can follow

Helpful knowledge and how you'll work

Technical knowledge that will help you succeed

Proficiency with SAS/Base, SAS Macro, R, or Minitab
Familiarity with general clinical laboratory operations and procedures
Basic knowledge of FDA Design Control and Quality System Regulation (QSR) requirements
Basic knowledge of FDA and EU submission processes and guidelines for IVD and In Vitro Diagnostic Regulation (IVDR) submissions
Basic knowledge of Clinical and Laboratory Standards Institute (CLSI) guidelines, FDA guidance documents, and International Organization for Standardization (ISO) documents
Ability to design experiments that test a clear, concise hypothesis

Streck Offerings

A challenging, safe and rewarding work environment
No night or weekend shifts
Excellent work life balance
Market competitive pay
Comprehensive and inclusive benefits
Great team environment
On and off campus career development opportunities

Visit www.streckcareers.com to learn more about Streck and apply for this opportunity.

Streck is an Equal Employment Opportunity Employer/Individuals with Disabilities & Protected Veterans/Affirmative Action employer and forbids discrimination against any employee or applicant because of race, color, religion, gender (including pregnancy, gender stereotyping and caregiver status), sexual orientation, gender identity, transgender status, national origin, disability, genetic information, citizenship, marital status or status as a covered veteran in accordance with applicable federal, state and local laws.

About the Company

Streck

Clinical laboratory products for accurate diagnostics

Streck makes products and solutions for clinical and research laboratories to help them deliver accurate test results. Their offerings include reagents, controls, and other lab materials used in diagnostics, helping labs advance diagnostic workflows and support better patient outcomes. The products are manufactured in La Vista, Nebraska and shipped to thousands of labs worldwide, enabling broad accessibility and consistent performance across sites. Streck differentiates itself through its long history (founded in 1971), established manufacturing base, and global reach, which together emphasize reliability, quality control, and support for diverse lab needs. The company’s goal is to enable laboratories to provide reliable results that improve diagnoses and patient health.

Company size: 201-500
Company stage: Not listed
Total funding: Not listed
Headquarters: La Vista, NE
Founded: 1971

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