Director of Biostatistics

About the role

As Lindus Therapeutics builds out its portfolio through in-licensing, the Director of Biostatistics owns statistical strategy across that portfolio and stays hands-on, personally leading the statistics on live programmes from protocol through clinical study report. It's a genuine coach-player role - as much applied biostatistician as director.

This seat carries real weight: the statistical rigour of an incoming asset's data package shapes deal terms and development risk, and it's Lindus Therapeutics' primary statistical voice with regulators. You'll work closely with clinical, medical, data architecture, and business development colleagues, and build out the wider biostatistics function as the portfolio grows - with a clear path to Senior Director , then VP .

About you

We'd like to hear from you if…

• PhD in statistics or biostatistics with 10+ years' relevant pharma/biotech experience, or MS with 15+ years , including lead statistician experience across multiple Phase I/II programmes ( Phase III and CSR experience a plus )

• Personally interacted with health authorities on at least one programme, ideally an early-phase IND ( NDA also acceptable ), including formal meetings or written correspondence; FDA preferred, EMA also considered . Adaptive trial design experience required

• Experience setting statistical strategy at a 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 , and familiarity with applying AI/ML tools to statistical workflows a plus

• Experience evaluating external clinical data through due diligence, licensing, or M&A activity is a plus

• Comfortable operating as both a leader and a hands-on contributor, with excellent written and verbal communication skills across technical and non-technical audiences

What you'll focus on

• Statistical strategy & functional leadership: Set statistical strategy across the portfolio as it grows, and lead the biostatistics, statistical programming, and medical writing functions - priorities, ways of working, hiring, and SOPs.

• Lead statistician on active programmes: Personally lead the statistics on active and incoming programmes, from protocol development through database lock and clinical study report - authoring and reviewing SAPs , sample size and power calculations, and randomisation schemes, and reviewing output at key milestones including interim analyses and DSMB packages .

• Regulatory representation: Serve as the primary statistical voice with regulators - meetings, briefing documents, and responses to health authority queries - and author and review the statistical sections of regulatory submissions, including IND and NDA filings .

• Due diligence & asset evaluation: Assess the statistical rigour of clinical data packages for assets under consideration for in-licensing - trial design quality, endpoint selection, strength of signal - and flag statistical risk that could affect development strategy or deal terms.

• Delivery oversight & innovation: Oversee statistical programming deliverables (analysis datasets, tables, listings, figures, consistent with CDISC standards ) and medical writing output for CSRs and submissions , evaluate external CRO/FSP partnerships where needed, and identify where AI and machine learning tools can meaningfully improve statistical workflows.