Staff Biostatistician (Clinical Validation)

Ladders; États-Unis; À distance; USD 164 000 - 205 000; Plein temps

Avantages offerts par ce poste

Remote work opportunity

Mentorship and professional growth

Collaborative cross-functional team

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

R (4+ years)

Biostatistics

CDx/IVD experience

NGS data handling

Regulatory knowledge

Formation

PhD or Masters in Biostatistics/Statistics

Outils

R

NGS data analysis

Description du poste

For our client, we are seeking a Staff Biostatistician (Clinical Validation) to join the team of a leader in the Pharmaceuticals & Biotech space.

This role will lead the statistical design and analysis behind clinical validation efforts that support regulated diagnostic approvals. You will partner closely with cross-functional teams to ensure rigorous methodologies, clear documentation, and sound evidence generation for high-priority programs. The position also provides the opportunity to mentor junior team members while contributing to publications and ongoing scientific advancement.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $164,000 – $205,000 annually

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

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 next-generation sequencing (NGS) and genetic data
• 4+ years of practical experience with R statistical analysis software

Benefits

• Remote work opportunity
• Collaborative cross-functional team environment
• Opportunity to work on high-impact projects in molecular diagnostics
• Professional development and mentorship opportunities
• Engagement with regulatory authorities and industry advancements

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.