Lead Biostatistician – Clinical Trials & Data Strategy (Remote)

Terumo Neuro; United States; Hybrid; USD 123,000 - 164,000; Full time

Benefits offered by this job

PTO 15 days

Tuition reimbursement

Hybrid/Remote options

DEI focus

Job summary

Terumo Neuro is seeking a Biostatistician to lead the application of statistical methods across clinical trials and post-market analyses. You will design studies, develop SAPs, and guide cross-functional teams to ensure robust analyses.

You will generate SAS outputs for submissions, contribute to protocol development, and stay current with FDA guidance and data standards while supporting regulatory and medical affairs. Travel up to 10% may be required.

Qualifications

• PhD in biostatistics or statistics.
• At least five years of statistical methods experience in pharma/biotech.
• At least one year of lead or management experience.
• Excellent written and verbal communication skills.
• Proficient with Microsoft Office suite.

Responsibilities

• Lead statistical design and analysis for clinical trials and post-market data.
• Develop SAPs for all study phases and ensure alignment with protocols.
• Produce SAS tables, figures, and reports for submissions and publications.
• Provide statistical consultation to cross-functional clinical and regulatory teams.
• Create SOPs for analysis of clinical study data and QA of statistical outputs.
• Support Regulatory Affairs, QA, and Medical Affairs with data reviews.
• Stay current with regulatory guidance (FDA/ICH) and data standards.
• Travel up to 10% domestically/internationally.

Skills

Leadership/management

Communication

Project management

Statistical knowledge

Education

Ph.D. in biostatistics or statistics

Tools

SAS

Oracle Clinical

UNIX

S-plus/R

Microsoft Office

Job description

Terumo Neuro is seeking a Biostatistician to lead the application of statistical methods across clinical trials and post-market analyses. You will design studies, develop SAPs, and guide cross-functional teams to ensure robust analyses.

You will generate SAS outputs for submissions, contribute to protocol development, and stay current with FDA guidance and data standards while supporting regulatory and medical affairs. Travel up to 10% may be required.