Senior Director of Biostatistics

Lindus; United States; On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Competitive salary

Stock options

Health insurance

Wellness allowance

Learning & development allowance

Parental leave

Team events

Job summary

Lindus Therapeutics seeks a Senior Director of Biostatistics to own statistical strategy across a growing asset portfolio. You will be hands-on leading statistics on live programmes from protocol development to database lock and CSR, while shaping team direction and processes.

You’ll collaborate with clinical, regulatory, data, and business teams to align study design with regulatory expectations and deal terms, building a scalable biostatistics function as Lindus expands its portfolio.

Qualifications

• PhD in statistics or biostatistics with 10+ years pharma/biotech experience, or MS with 15+ years, including lead statistician experience across multiple early-phase programmes, including CSR.
• Experience interacting with health authorities on INDs/NDAs, 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 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, with excellent written and verbal communication skills across executive, technical, and non-technical audiences.

Responsibilities

• 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/reviewing SAPs, sample size and power calculations, and randomisation schemes.
• Regulatory representation: Serve as the primary statistical voice with regulators - meetings, briefing documents, and responses to health authority queries - and author/review statistical sections of submissions.
• Due diligence & asset evaluation: Assess statistical rigour of data packages for assets under consideration for in-licensing - trial design quality, endpoint selection, strength of signal.
• Delivery oversight & innovation: Oversee statistical programming deliverables and medical writing output for CSRs and submissions; evaluate CRO/FSP partnerships; explore AI/ML tool applications.

Skills

Statistical leadership

Regulatory interaction

Clinical trial design

R/SAS programming

AI/ML in statistics

Data due diligence

Team building

Education

PhD in statistics or biostatistics

MS in statistics (15+ years)

Tools

R

SAS

Job description

Our mission

Great science regularly stalls in the clinic, not because the science is wrong, but because the company behind it lacks the capital, infrastructure, or focus to take it all the way through. Today’s clinical-stage biopharma model is broken, and as a result promising treatments never reach patients.

Our mission

Great science regularly stalls in the clinic, not because the science is wrong, but because the company behind it lacks the capital, infrastructure, or focus to take it all the way through. Today’s clinical-stage biopharma model is broken, and as a result promising treatments never reach patients.

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

We’re in-licensing 5-7 clinical-stage, typically Phase-2-ready assets, funded directly from Lindus Health’s balance sheet. We’re targeting deal close on our first assets through 2026, with first trials launching in H1 2027.

About The Role

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.

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 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, 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 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, with excellent written and verbal communication skills across executive, 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.

What we offer

Make an impact across all areas of our business and fix one of the world's most broken industries.

• 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
• Charity events and fundraising opportunities through our charity partnership with the Forward Trust

Our hiring process

• Initial conversation with our Senior Talent Partner, Cam (30 minutes)
• Second conversation with the VP of Data (30 minutes)
• Technical interview with Biostatistics experts (45 minutes)
• Values interview with 2 Senior Leadership Team members (30 minutes)

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