Teams at Lindus Therapeutics

Own portfolio-wide statistical strategy and lead biostatistics, programming, and medical writing functions. Personally serve as lead statistician across clinical programs from protocol design through database lock and clinical study reports. Represent statistics in FDA and EMA interactions, regulatory submissions, and due diligence for in-licensed assets. Oversee adaptive trial designs, SAPs, analyses, CDISC-compliant outputs, CRO partnerships, hiring, team development, and process standards.

Build and manage clinical studies within the Citrus ecosystem, including data collection forms, integrations, pipelines, validation, user access, quality checks, and go-live coordination. Support live-study changes, data corrections, warehouse troubleshooting, automated workflows, and core codebase contributions. Collaborate with data architects and trial teams while maintaining accurate, compliant documentation suitable for audits and inspections.

Own clinical and regulatory delivery for a Phase 2 trial from start-up through close-out, ensuring quality, budget, timelines, and safety. Lead and mentor Clinical Operations staff, provide portfolio-wide operational sign-off, shape SOPs and risk-based processes, review essential trial documentation, and advise on trial design, quality, and safety decisions. Partner with medical, quality, product, and corporate development teams across multiple assets and jurisdictions, with emphasis on complex neurology and FDA-facing trials.