Director, Biostatistics & Regulatory Strategy

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

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.