Sr. Director - Biostatistics, Neurology

Lead statistical strategy for GondolaBio's ASO assets from early FIH through proof-of-concept, including development and defense of fit-for-purpose SAPs for small-sample, placebo/open-label designs with high inter-patient variability. Design robust seizure-endpoint and exploratory analyses for rare-disease populations; apply Bayesian and adaptive design elements, including n-of-1 and natural history benchmarking, to mitigate risk from variability and limited power. Provide regulatory statistical support for INDs, briefing documents, and FDA/EMA interactions; contribute to pre-IND and Type B/C meetings. Collaborate across Clinical Development, Regulatory, Pharmacology, Translational, and external CROs/vendors to embed statistical considerations early in protocol development, CRF design, data management, and study conduct. Represent Statistics in cross-functional program team meetings.