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Lindus Therapeutics 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 is in-licensing 5-7 clinical-stage, typically Phase-2-ready assets, with first trials launching in H1 2027.
As Senior Director of Biostatistics, you will own statistical strategy across the growing portfolio and serve as both a hands-on biostatistician and leader. This is a coach-player role: you'll personally lead statistics on live programmes from protocol development through database lock and clinical study report, while also building out the biostatistics, statistical programming, and medical writing functions as the portfolio scales.
Key responsibilities include:
- Setting statistical strategy across the portfolio and leading the biostatistics, statistical programming, and medical writing functions—priorities, ways of working, hiring, and SOPs.
- Personally leading statistics on active and incoming programmes, authoring and reviewing Statistical Analysis Plans (SAPs), sample size and power calculations, randomisation schemes, and reviewing output at key milestones including interim analyses and DSMB packages.
- Serving as the primary statistical voice with regulators—meetings, briefing documents, responses to health authority queries, and authoring/reviewing statistical sections of regulatory submissions (IND and NDA filings).
- Assessing the statistical rigour of clinical data packages for in-licensing candidates, evaluating trial design quality, endpoint selection, and strength of signal to flag statistical risk affecting development strategy or deal terms.
- Overseeing statistical programming deliverables (analysis datasets, tables, listings, figures consistent with CDISC standards) and medical writing output for CSRs and submissions; evaluating external CRO/FSP partnerships; identifying where AI and machine learning tools can improve statistical workflows.
You will work closely with clinical, medical, data architecture, clinical operations, regulatory, and business development teams. This role is critical because the statistical rigour of an incoming asset's data package directly shapes deal terms and development risk, and serves as Lindus Therapeutics' primary statistical interface with regulators.
REQUIREMENTS:
- PhD in statistics or biostatistics with 10+ years' relevant pharma/biotech experience, OR MS with 15+ years, including lead statistician experience across multiple early-phase programmes with at least one programme through Clinical Study Report (CSR).
- Personal interaction with health authorities on multiple programmes, ideally early-phase INDs (NDAs also acceptable), including formal meetings and written correspondence; FDA preferred, EMA also considered. Adaptive trial design experience required.
- Experience setting statistical strategy at programme or portfolio level, with strong knowledge of CDISC standards, regulatory submission requirements, and current drug development trends.
- Excellent programming skills, including independently generating analysis output; R and/or SAS fluency preferred; familiarity with applying AI/ML tools to statistical workflows a plus.
- Experience evaluating external clinical data through due diligence, licensing, or M&A activity strongly preferred.
- Track record of hiring, managing, and developing statisticians, ideally including building or scaling a biostatistics function.
- Comfortable operating as both a leader and hands-on contributor, with excellent written and verbal communication skills across executive, technical, and non-technical audiences.
