Senior Staff Biostatistician (Remote)

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

Job summary

A leading medical device company is seeking a Senior Staff Biostatistician to lead statistical strategy for clinical trials. This remote role involves collaborating with teams to optimize study design, ensuring regulatory readiness, and contributing to scientific publications. Candidates should have extensive experience in biostatistics and proficiency in SAS programming.

Benefits

Bonus eligible

Benefits

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.
• Provide statistical input for regulatory submissions.

Skills

SAS Programming

Statistical Concepts

Data Analysis

Education

Bachelor’s degree in Biostatistics

MS or PhD in Statistics

Tools

SQL

SAS Macros

R Programming

Job description

Work Flexibility: Remote

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

• Lead statistical planning and analysis for clinical trials, including development of statistical analysis plans (SAPs) and interpretation of complex data

• Design and validate SAS programs to generate clinical datasets, tables, listings, and figures (TLGs) in compliance with regulatory standards

• Collaborate with cross-functional teams—including clinical scientists, regulatory affairs, and neurointerventional physicians—to optimize study design and endpoints

• Provide statistical input for regulatory submissions (e.g., FDA, EU MDR) and support clinical study reports (CSRs)

• Contribute to scientific publications and conference presentations to communicate clinical evidence

• Ensure statistical best practices across projects

• Stay current with evolving regulatory guidance and statistical methodologies relevant to medical devices

What you need

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

$100,500.00 - $215,300.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location.Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: 0%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.