Director of Biostatistics

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

Benefits offered by this job

Stock options

27 days annual leave

Health insurance

Wellness allowance

Parental leave

Learning and Development allowance

Team events

Gym and retail discounts

Lunch voucher

Charity events

Job summary

Lindus Health is seeking a Director of Biostatistics to own statistical strategy across a growing clinical portfolio. You will lead biostatistics, programming, and medical writing, and work hands-on on live programmes from protocol development through CSR.

This role blends leadership with technical execution to shape regulatory submissions and deal terms. You will interact with regulators, design endpoints, align study execution with statistics, and help build the team as the portfolio expands.

Qualifications

• PhD in statistics or biostatistics with 10+ years pharma/biotech experience, or MS with 15+ years, including lead statistician experience across multiple Phase I/II programmes.
• Experience interacting with health authorities on programmes, including formal meetings or correspondence; FDA preferred, EMA considered. Adaptive trial design experience required.
• Strong knowledge of CDISC standards, regulatory submission requirements, and current drug development trends.
• Excellent programming skills with ability to generate analysis output; R and/or SAS fluency; familiarity with applying AI/ML tools to statistical workflows.

Responsibilities

• Set statistical strategy across the portfolio as it grows; lead the biostatistics, programming, and medical writing functions; define priorities and SOPs.
• Lead statistician on active programmes: protocol development, database lock, CSR review; author/review SAPs, sample size calculations, randomisation schemes.
• Regulatory representation: primary statistical voice with regulators; author/review statistical sections of IND/NDA submissions.
• Due diligence & asset evaluation: assess statistical rigor of data packages; flag statistical risks affecting strategy or deal terms.
• Delivery oversight & innovation: oversee programming deliverables and medical writing output; evaluate CRO/FSP partnerships; explore AI/ML improvements.

Skills

PhD in statistics or biostatistics

Lead statistician experience

FDA / health authority meetings

CDISC standards knowledge

R and/or SAS

AI/ML in statistics

External data due diligence

Strong communication

Education

PhD in statistics or biostatistics

MS with 15+ years

Tools

R

SAS

AI/ML tools for statistics

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 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 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: as much applied biostatistician as director, 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 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.

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

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.