Director of Biostatistics

Our mission is to fix the broken clinical-stage biopharma model by in-licensing clinical-stage therapeutic assets and developing them through Lindus Health’s integrated, technology-first clinical trial infrastructure. We’re building on a proven foundation that has delivered 82% of Lindus Health’s sponsor trials on or ahead of timeline, across 40+ completed trials across the US and Europe.

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. This role 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.

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:

• 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.
• 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.
• 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.
• 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.
• 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.

What we offer (UK):

• Competitive salary, plus meaningful stock options.
• Flexible working: We have an incredible office near London Bridge and encourage people to work 3 days per week from the office.
• 30 days annual leave in addition to Bank Holidays.
• £60 monthly wellness allowance, which you can spend on our company health insurance scheme through AXA, a wellhub membership, or wellness activities and expenses of your choice!
• Enhanced Parental Leave: 16 weeks full pay for primary caregiver and 6 weeks full pay for secondary caregiver.
• £1,000 Learning and Development allowance each year to put towards courses, certifications, and development.
• Regular whole company and team events, both in person and virtually.
• Access to gym and retail discounts through our benefits platform Happl.
• A well-stocked pantry and drinks fridge, Monday breakfast spread and catered team lunch on a Thursday for the UK office every week!
• Cycle-to-work scheme and other salary sacrifice options available.
• Charity events and fundraising opportunities through our charity partnership with the Forward Trust.

Our hiring process includes an initial conversation with our Senior Talent Partner, a second conversation with the VP of Data, a technical interview with Biostatistics experts, and a values interview with 2 Senior Leadership Team members. We will only contact you from lindushealth.com email addresses. Please check the spelling of emails which appear to come from Lindus carefully before responding. We will never ask for your financial information over email.

We are an equal opportunity employer committed to building a diverse and inclusive workforce. We evaluate all candidates based solely on their skills, experience, and qualifications relevant to the role. We do not discriminate on the basis of race, ethnicity, religion, gender, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected status.