Biostatistical Analyst

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

About Streck :Streck is aNebraska-basedmanufacturing company that makes a global impactbydeveloping anddistributing tolabs worldwide. Ourproductsprovide confidenceforaccuratehealth caretesting! Ourpassions andpriorities are focusedontaking care ofour customers,employees,andgiving back to ourcommunity. Streck has jobsfor every stage ofyourcareer.If you are a dependable, hard-working, and team-oriented individual who values meaningful work, Streck is looking for youto join ourcommunity of passionate people on amission!

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 is an EqualEmploymentOpportunityEmployer/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.