Senior Biostatistician, Clinical Validation (Remote)

Ladders; United States; Remote; USD 164,000 - 205,000; Full time

Benefits offered by this job

Remote work opportunity

Mentorship and professional growth

Collaborative cross-functional team

Job summary

Ladders is seeking a Staff Biostatistician (Clinical Validation) to lead statistical design and analysis behind clinical validation efforts for regulated diagnostic approvals. You will partner with cross-functional teams to ensure rigorous methodologies and sound evidence generation for high-priority programs.

The role offers remote work for US-based candidates, with compensation between $164,000 and $205,000 annually and opportunities to mentor junior members and contribute to publications and

Qualifications

• Ph.D. or Master’s degree in Biostatistics, Statistics, or a related field.
• 8+ years of industry experience in molecular diagnostics or biotechnology.
• Experience in regulated environments with CDx or IVD submissions.
• Proficiency in handling next-generation sequencing (NGS) and genetic data.
• 4+ years of practical experience with R statistical analysis software.

Responsibilities

• Lead the design and analysis of clinical validation studies for diagnostic approvals.
• Ensure compliance with FDA standards in statistical methodologies.
• Prepare statistical analysis protocols and reports for stakeholders.
• Act as the statistical lead on high-priority project teams.
• Drive execution of impactful clinical trials and research publications.
• Stay updated on advancements in biostatistics and clinical validation.
• Mentor junior team members and provide technical supervision.

Skills

R (4+ years)

Biostatistics

CDx/IVD experience

NGS data handling

Regulatory knowledge

Education

PhD or Masters in Biostatistics/Statistics

Tools

R

NGS data analysis

Job description

Ladders is seeking a Staff Biostatistician (Clinical Validation) to lead statistical design and analysis behind clinical validation efforts for regulated diagnostic approvals. You will partner with cross-functional teams to ensure rigorous methodologies and sound evidence generation for high-priority programs.

The role offers remote work for US-based candidates, with compensation between $164,000 and $205,000 annually and opportunities to mentor junior members and contribute to publications and