VP Biostatistics, Ophthalmic Gene Therapy Biotech

VP or Senior VP, BiostatisticsDepartment: Clinical Development | Location: Durham, NC (Hybrid/Remote Options Considered)

Do not wait to apply after reading this description a high application volume is expected for this opportunity.
About Opus GeneticsOpus 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 OpportunityWe 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 DoLead all biostatistical strategy and execution across Opus Genetics' clinical development pipelineServe as primary statistical lead for FDA, EMA, and other global regulatory interactionsContribute to clinical development plans, protocol design, endpoint selection, SAPs, and regulatory submissions (IND, BLA, MAA)Oversee interim analyses, DMC activities, and adaptive trial design strategiesPartner with Clinical Operations, Regulatory Affairs, and Medical Affairs on program strategy and data interpretationPresent statistical findings to executive leadership, board, and investorsOversee CROs and external statistical programming vendors
What We're Looking ForPhD in Biostatistics, Statistics, Mathematics, or related quantitative field (Master's with extensive industry experience considered)15+ years of progressive biostatistics leadership in biotech or pharmaDemonstrated success leading statistical strategy for registration-enabling programsExperience with NDA, BLA, and/or MAA submissions and regulatory approvalsProven track record building and leading biostatistics functionsDeep knowledge of ICH, FDA, and EMA statistical guidanceExpertise in adaptive trial design, rare disease development, CDISC, and statistical computing (SAS, R)
PreferredGene therapy or ophthalmology clinical development experiencePrior statistical lead role in FDA advisory committee or health authority meetingsExperience with natural history studies and external control methodologiesBackground 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. xzbcwsv Competitive compensation, equity participation, comprehensive benefits, and a flexible work environment.