VP Biostatistics, Ophthalmic Gene Therapy Biotech (Durham)

VP or Senior VP, Biostatistics

Department: Clinical Development | Location: Durham, NC (Hybrid/Remote Options Considered)

About Opus Genetics

Opus Genetics is a clinical-stage biotechnology company on a mission to develop transformational gene therapies for patients with inherited retinal diseases. We operate at the intersection of cutting-edge science and urgent unmet need - with programs advancing toward pivotal stages and regulatory milestones that matter.

The Opportunity

We are looking for a VP or Senior VP of Biostatistics to join our Clinical Development team and serve as the statistical architect for our entire clinical portfolio. Reporting to the Chief Medical Officer, this hands-on leader will own statistical strategy from early-stage design through BLA submission - and will be a visible, trusted voice with the FDA, our board, and our investors.

This is a rare opportunity to build a biostatistics function from the ground up at a company where your work will have direct impact on patients with vision-threatening diseases.

What You'll Do

• Lead all biostatistical strategy and execution across Opus Genetics' clinical development pipeline
• Serve as primary statistical lead for FDA, EMA, and other global regulatory interactions
• Contribute to clinical development plans, protocol design, endpoint selection, SAPs, and regulatory submissions (IND, BLA, MAA)
• Oversee interim analyses, DMC activities, and adaptive trial design strategies
• Partner with Clinical Operations, Regulatory Affairs, and Medical Affairs on program strategy and data interpretation
• Present statistical findings to executive leadership, board, and investors
• Oversee CROs and external statistical programming vendors

What We're Looking For

• PhD in Biostatistics, Statistics, Mathematics, or related quantitative field (Master's with extensive industry experience considered)
• 15+ years of progressive biostatistics leadership in biotech or pharma
• Demonstrated success leading statistical strategy for registration-enabling programs
• Experience with NDA, BLA, and/or MAA submissions and regulatory approvals
• Proven track record building and leading biostatistics functions
• Deep knowledge of ICH, FDA, and EMA statistical guidance
• Expertise in adaptive trial design, rare disease development, CDISC, and statistical computing (SAS, R)

Preferred

• Gene therapy or ophthalmology clinical development experience
• Prior statistical lead role in FDA advisory committee or health authority meetings
• Experience with natural history studies and external control methodologies
• Background in emerging growth biotechnology companies

Why Opus?

At Opus Genetics, you'll work alongside a passionate, expert team that moves fast, thinks big, and shows up for patients. Competitive compensation, equity participation, comprehensive benefits, and a flexible work environment.