Senior Director of Biostatistics

Lindus

9d • Remote

About The Position

As Lindus Therapeutics builds out its portfolio through in-licensing, biostatistics sits at the centre of nearly every decision that follows - which assets are worth pursuing, how trials are designed, and what evidence ultimately reaches regulators. The Senior Director of Biostatistics owns statistical strategy across that growing portfolio and, given the size of the team today, stays hands-on personally leading the statistics on live programmes from protocol development through database lock and clinical study report. This is very much a coach-player role to start: as much applied biostatistician as leader, willing to roll up your sleeves alongside setting the team's direction.
This role matters because the statistical rigour of an incoming asset's data package directly shapes deal terms and development risk - without a strong statistical voice at the table during due diligence, weak signals get missed and genuinely promising ones get under-valued. It's also Lindus Therapeutics' primary statistical interface with regulators, so the credibility of every regulatory interaction rests on this seat.
You'll work closely with the clinical and medical teams on endpoint selection and trial design, with data architecture and clinical operations to align statistics with study execution, and alongside clinical, regulatory, and business development colleagues in due diligence discussions on prospective in-licensing targets. You'll also build out the biostatistics, statistical programming, and medical writing functions as the portfolio grows, and set the team's processes and standards as you go.

Requirements

• PhD in statistics or biostatistics with 10+ years' relevant pharma/biotech experience, or MS with 15+ years
• Lead statistician experience across multiple early-phase programmes, including at least one programme through CSR
• Personally interacted 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 a programme or portfolio level
• 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 is 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 a hands-on contributor
• Excellent written and verbal communication skills across executive, technical, and non-technical audiences

Nice To Haves

• 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 strongly preferred
• Ideally early-phase INDs (NDAs also acceptable), including formal meetings and written correspondence; FDA preferred, EMA also considered.

Responsibilities

• 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.

Benefits

• Competitive salary, plus meaningful stock options
• 27 days annual leave in addition to 11 National Holidays
• Health insurance coverage through our PEO Trinet
• $40 monthly wellness allowance, which you can spend on 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
• $2,000 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
• Monthly lunch voucher for our remote teams

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree