Biostatistical Analyst

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

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

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.