VP Biostatistics, Ophthalmic Gene Therapy Biotech

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.