Senior Director of Biostatistics

The role

The Senior Director of Biostatistics owns statistical strategy across a growing portfolio of in-licensed assets. This coach-player role involves personally leading statistics on live programmes from protocol development through database lock and clinical study report.

What you will do

• Set statistical strategy across the portfolio and lead biostatistics, statistical programming, and medical writing functions.
• Personally lead statistics on active and incoming programmes from protocol development through database lock and clinical study report.
• Author and review SAPs, sample size and power calculations, and randomisation schemes.
• Review output at key milestones including interim analyses and DSMB packages.
• Serve as the primary statistical voice with regulators through meetings, briefing documents, and responses to queries.
• Author and review statistical sections of regulatory submissions including IND and NDA filings.
• Assess statistical rigour of clinical data packages for assets under consideration for in-licensing.
• Oversee statistical programming deliverables consistent with CDISC standards.
• Evaluate external CRO/FSP partnerships where needed.
• Identify where AI and machine learning tools can improve statistical workflows.

Required qualifications

• 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, including formal meetings and written correspondence.
• 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.
• Track record of hiring, managing, and developing statisticians.

Nice to have

• FDA preferred for health authority interaction, EMA also considered.
• 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.
• Ideally including building or scaling a biostatistics function.

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
• 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
• 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 with the Forward Trust

Before you apply

• Initial conversation with Senior Talent Partner
• Second conversation with the VP of Data
• Technical interview with Biostatistics experts
• Values interview with 2 Senior Leadership Team members

About the company

Lindus Health is building the next generation of biopharma by in-licensing clinical-stage therapeutic assets and developing them through an integrated, technology-first clinical trial infrastructure.