Senior Director – Biostatistics, Neurology

🕒 Julho 14

🏄 California – Remoto

🏄 California – Remote

💵 $300.000 - $360.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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GondolaBio

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2024

🏥 Saúde

💼 Consultoria

🏭 Manufatura

💰 $300.000.000 Venture Round - GondolaBio em 2024-08

Healthcare • Consulting • Manufacturing

A GondolaBio é uma empresa biofarmacêutica em estágio clínico lançada em 2024 e afiliada à BridgeBio Pharma, focada no desenvolvimento de terapias revolucionárias para pacientes com doenças genéticas. A empresa adota uma abordagem enxuta e descentralizada para acelerar a pesquisa e o desenvolvimento em estágio inicial através de múltiplas modalidades (incluindo pequenas moléculas e terapias com oligonucleotídeos) e está construindo um pipeline diversificado visando condições genéticas raras e pouco atendidas, como EPP/XLP, com seu programa principal PORT-77. A GondolaBio coloca as necessidades dos pacientes em primeiro lugar e busca levar tratamentos que modifiquem doenças de forma mais rápida para populações que não possuem terapias aprovadas.

Descrição

• Statistical leadership for ASO programs (Phase 1/2 to PoC readiness): Serve as the lead statistician for GondolaBio's ASO assets, owning statistical strategy from early FIH through proof-of-concept. • Develop and defend fit-for-purpose statistical analysis plans (SAPs) that account for small sample sizes, placebo and open-label designs, and high inter-patient variability. • Seizure endpoint strategy: Design robust statistical approaches for seizure frequency and responder analyses in Developmental and Epileptic Encephalopathy populations, where within-patient variability, seizure clustering, and non-normality require non-standard methods. • Partner with clinical colleagues to define scientifically credible and regulatorily acceptable primary and secondary endpoints. • Rare disease-adapted trial design: Apply specialized methods appropriate for small N studies including Bayesian frameworks, adaptive designs, n-of-1 elements, and natural history benchmarking. • Proactively identify and mitigate risks from high variability, missing data, and limited statistical power, communicating trade-offs clearly to program leadership. • Regulatory statistical support: Prepare and contribute to statistical sections of INDs, briefing documents, and FDA/EMA meeting packages. Support pre-IND and Type B/C meetings, and respond to agency questions on statistical methodology. • Biomarker and exploratory analysis: Collaborate with Pharmacology, Translational, and Clinical teams to develop analysis plans for PD biomarkers, target engagement endpoints, and patient stratification. Apply appropriate multiplicity controls and exploratory frameworks to preserve interpretability. • Cross-functional collaboration: Partner closely with Clinical Development, Regulatory, Clinical Operations, and external CROs/vendors to ensure statistical considerations are embedded early in protocol development, CRF design, data management, and study conduct. Represent Statistics in cross-functional program team meetings.

🎯 Requisitos

• M.S. or Ph.D. in Biostatistics, Statistics, or a closely related field. • 8+ years of pharmaceutical/biotech industry experience, with meaningful early-phase (Phase 1/2) rare disease exposure. • Demonstrated experience designing and analyzing seizure trials (e.g., DEE, TSC, Dravet, LGS) or other high-variability neurological endpoints. • Deep familiarity with statistical challenges specific to rare disease: small sample sizes, open-label designs, natural history controls, and high inter-patient variability. • Hands-on proficiency with SAS and/or R; ability to program and review analysis datasets and outputs independently. • Experience authoring and defending SAPs, study reports, and regulatory-facing statistical documents. • Comfort operating in lean, fast-paced biotech environments with significant autonomy and accountability. • Nice-to-Haves • Experience with Bayesian or adaptive design methodologies in rare or neurological disease trials. • Familiarity with PRO/ClinRO endpoint development and validation in pediatric or rare disease populations. • Experience with responder analyses, seizure diary data, and mixed-effects models for repeated measures (MMRM) in epilepsy studies. • Exposure to seamless Phase 1/2 designs or platform trials. • Experience interfacing directly with FDA or EMA on statistical methodology for rare disease.

🏖️ Benefícios

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak • An unyielding commitment to always putting patients first • A decentralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science • A place where you own the vision – both for your program and your own career path • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game • Access to learning and development resources to help you get in the best professional shape of your life • Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs) • Flexible PTO • Rapid career advancement for strong performers • Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time • Commitment to Diversity, Equity & Inclusion