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Director of Biostatistics

Lindus Health - London, England, United Kingdom - Hybrid - posted 2026-08-28

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Lindus Therapeutics is building a next-generation biopharma company by in-licensing clinical-stage therapeutic assets and developing them through an integrated, technology-first clinical trial infrastructure. The company is in-licensing 5-7 Phase-2-ready assets with first trials launching in H1 2027. As Director of Biostatistics, you will own statistical strategy across the growing portfolio while remaining hands-on, personally leading statistics on live programmes from protocol through clinical study report. This is a genuine coach-player role combining applied biostatistics with directorship responsibilities. Key responsibilities include: setting statistical strategy across the portfolio and leading the biostatistics, statistical programming, and medical writing functions; personally leading statistics on active and incoming programmes from protocol development through database lock and clinical study report; serving as the primary statistical voice with regulators in meetings, briefing documents, and health authority responses; assessing statistical rigour of clinical data packages for in-licensing candidates; and overseeing statistical programming deliverables consistent with CDISC standards while identifying opportunities for AI/ML tool integration. You will work closely with clinical, medical, data architecture, and business development colleagues. The role carries real weight: statistical rigour shapes deal terms and development risk, and you'll be Lindus Therapeutics' primary statistical voice with regulatory authorities. Required qualifications: PhD in statistics/biostatistics with 10+ years pharma/biotech experience, or MS with 15+ years, including lead statistician experience across multiple Phase I/II programmes. You must have personally interacted with health authorities on at least one programme (FDA preferred, EMA considered), including formal meetings or written correspondence. Adaptive trial design experience is required. You need strong knowledge of CDISC standards, regulatory submission requirements, and current drug development trends. Excellent programming skills in R and/or SAS are essential, with familiarity in AI/ML tools for statistical workflows a plus. Experience evaluating external clinical data through due diligence, licensing, or M&A is advantageous. The company offers competitive salary with meaningful stock options, flexible working (3 days per week in office near London Bridge), 30 days annual leave plus bank holidays, £60 monthly wellness allowance, enhanced parental leave (16 weeks full pay for primary caregiver), £1,000 annual L&D allowance, gym and retail discounts, cycle-to-work scheme, and regular company and team events.

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