Associate Director, Biostatistics
Core
Provide strategic statistical input and technical expertise to lead clinical trial projects for late-stage biotechnology programs, specifically in ophthalmology and gene therapy.
Role type
Senior IC biostatistician (Associate Director)
Builds
Clinical trial statistical analysis plans, randomization schemas, and regulatory reports for Phase 3+ therapeutics
Domain
Biotechnology / Clinical Trials / Ophthalmology / Gene Therapy
Required skills
Statistical methodology, study design, protocol development, SAP development, randomization schema design, data analysis, CRF/EDC development, statistical programming oversight, CDISC/SDTM/ADaM standards, GCP/ICH regulations
Preferred skills
Ophthalmology domain expertise, biologic/gene therapy experience, full clinical phase (I-IV) experience
Technologies
CDISC, SDTM, ADaM, MedDRA, WHODRUG
Responsibilities
Collaborate on study design and protocol development; Develop statistical analysis plans and randomization schemas; Perform data analysis and ensure quality of outsourced deliverables; Interpret data results for study reports and publications; Ensure robust data collection via CRF/EDC development
Seniority
Senior, hands-on IC with strategic input