Senior Staff Biostatistician (Remote)

Stryker; Tennessee; Remote; USD 100,000 - 216,000; Full time

Job summary

A leading company in medical devices is seeking a Senior Staff Biostatistician to lead statistical strategy for clinical trials. This remote role involves statistical planning, analysis, and collaboration with various teams to ensure regulatory compliance and advance patient care through data-driven insights.

Benefits

Health Insurance

HSA

FSA

401(k)

Stock Purchase Plans

Qualifications

• 6+ years of experience in clinical biostatistics.
• Experience with clinical trial data analysis and regulatory documentation.

Responsibilities

• Lead statistical planning and analysis for clinical trials.
• Collaborate with cross-functional teams to optimize study design.

Skills

SAS Programming

Communication

Statistical Analysis

Education

Bachelor’s degree in Biostatistics

MS or PhD in Statistics

Tools

SQL

SAS Macros

R Programming

Job description

Join to apply for the Senior Staff Biostatistician (Remote) role at Stryker.

Stryker Neurovascular is seeking a Senior Staff Biostatistician to lead statistical strategy and execution for clinical trials supporting innovative neurointerventional medical devices. In this role, you will play a critical part in shaping clinical evidence, ensuring regulatory readiness, and advancing patient care through data-driven insights. This is a remote position to be located anywhere within the United States, preferably on the Central or Eastern time zone.

What You Will Do

1. Lead statistical planning and analysis for clinical trials, including development of statistical analysis plans (SAPs) and interpretation of complex data.
2. Design and validate SAS programs to generate clinical datasets, tables, listings, and figures (TLGs) in compliance with regulatory standards.
3. Collaborate with cross-functional teams—including clinical scientists, regulatory affairs, and neurointerventional physicians—to optimize study design and endpoints.
4. Provide statistical input for regulatory submissions (e.g., FDA, EU MDR) and support clinical study reports (CSRs).
5. Contribute to scientific publications and conference presentations to communicate clinical evidence.
6. Ensure statistical best practices across projects.
7. Stay current with evolving regulatory guidance and statistical methodologies relevant to medical devices.

Required

• Bachelor’s degree in Biostatistics, Engineering, Science, or related field.
• 6+ years of experience in clinical biostatistics.
• Proficiency in SAS programming; strong ability to communicate statistical concepts to non-statisticians.
• Experience with clinical trial data analysis, inferential statistics, and regulatory documentation.

Preferred

• MS or PhD in Statistics, Mathematics, or related field.
• 4+ years in medical device, pharmaceutical, or biotech settings.
• Experience with SQL, SAS Macros, and electronic data capture (EDC) systems.
• Experience in R programming.
• Prior contributions to peer-reviewed publications or scientific presentations.
• Familiarity with ISO 14155, FDA guidance, and EU MDR requirements.

Salary ranges from $100,500 to $215,300 plus bonus eligibility and benefits. Actual compensation varies based on location, skills, and experience. Benefits include health insurance, HSA, FSA, 401(k), stock purchase plans, and more.

Additional Information

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Research, Analyst, and Information Technology
• Industries: Appliances, Electrical, and Electronics Manufacturing, Industrial Machinery Manufacturing, Medical Equipment Manufacturing

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