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Staff Biostatistician

Lindus Health - United States - Hybrid - posted 2026-08-07

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Lindus Health is building the next generation of biopharma by in-licensing clinical-stage therapeutic assets and developing them through an integrated, technology-first clinical trial infrastructure. The company has delivered 82% of sponsor trials on or ahead of timeline across 40+ completed trials in the US and Europe, and is now launching Lindus Therapeutics to in-license 5-7 Phase-2-ready assets with first trials launching in H1 2027. You will serve as the senior technical authority on statistics at Lindus Therapeutics, a senior individual contributor role spanning the full lifecycle of drug assets: evaluating acquisition evidence, shaping trial design, owning analyses that determine programme advancement, and representing statistical positions directly to regulators. Key responsibilities include leading statistical assessment on asset acquisitions and delivering the final statistical verdict informing deal decisions; setting standards for trial design across the portfolio and leading design of the most complex trials (adaptive designs, novel endpoints, multi-cohort studies); owning interim and final analyses with material scientific, safety, or business consequence, including board-facing responsibility; serving as the senior statistical authority in regulatory interactions, authoring and defending statistical cases in briefing books and agency meetings; and building statistical standards, templates, and SOPs while mentoring other statisticians as the function grows. You will work closely with Clinical Operations, Data Architecture, Regulatory, and Corporate Development leadership, with your input shaping upstream decisions on individual trials and acquisitions. This role is critical because Lindus Therapeutics operates on a portfolio model with multiple clinical-stage assets carrying real acquisition, design, and regulatory risk; a senior statistician who can independently own judgement across multiple programmes simultaneously is essential to prevent bottlenecks. Required qualifications: PhD or Master's in Biostatistics, Statistics, or related field with 9+ years in clinical biostatistics, including preparation of statistical content for FDA submissions (IND, NDA, or BLA); demonstrated leadership of statistical strategy across multiple trials independently, including complex or adaptive designs; fluency in R or SAS while directing others' programming work; experience leading interim analyses with material go/no-go or safety consequences; and direct regulatory representation experience. You should be a trusted, credible statistical voice with Clinical Operations, Regulatory, and Corporate Development leadership.

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