VP or SVP Biostatistics, Ophthalmic Gene Therapy Biotech

Role: Senior leadership in biostatistics, serving as the statistical architect for Opus Genetics' clinical portfolio, including strategy development and regulatory interactions. Responsibilities: lead biostatistical strategy across clinical programs, oversee statistical aspects of protocol design, endpoint selection, interim analyses, adaptive trials, and regulatory submissions (IND, BLA, MAA); collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, and Medical Affairs; manage CROs and external vendors; present findings to leadership and regulators. Requirements: PhD in Biostatistics, Statistics, or related field (Master's with extensive experience considered); 15+ years in biotech/pharma biostatistics leadership; experience with NDA, BLA, MAA, and regulatory approval processes; expertise in adaptive trial design, rare disease, CDISC, and statistical computing (SAS, R); deep knowledge of ICH, FDA, EMA guidance. Preferred: gene therapy or ophthalmology experience; prior FDA advisory or health authority engagement; familiarity with natural history studies and external control methodologies; background in biotech startups. High-Value: leadership role in clinical development, global regulatory interactions, advanced statistical methodologies, biologics or gene therapies, pivotal stage programs. WorkSetup: hybrid/remote Durham, NC.