Lindus Therapeutics
Senior Director of Biostatistics
US · Remote · Director · Full-time · Posted Oct 6, 2026
- Experience
- 10+ years with a PhD, or 15+ years with an MS; includes lead statistician experience across multiple early-phase programs, including one through CSR.
- Education
- PhD in statistics or biostatistics, or MS.
About the job
Own portfolio-wide statistical strategy and personally lead biostatistics for clinical programs, including regulatory interactions, asset due diligence, and development of the biostatistics, programming, and medical writing functions.
What you'll do
- Set portfolio statistical strategy and lead functional priorities, hiring, processes, and SOPs.
- Lead study statistics from protocol development through database lock and clinical study report, including SAPs, sample size and power calculations, and analysis review.
- Represent statistics with health authorities, assess clinical data packages for in-licensing, and oversee programming and medical writing deliverables.
What they ask for
- PhD in statistics or biostatistics with 10+ years’ relevant pharma/biotech experience, or MS with 15+ years; lead statistician experience across multiple early-phase programs, including at least one through CSR.
- Personal health-authority interactions on multiple programs, including formal meetings and written correspondence; adaptive trial design experience.
- Portfolio- or program-level statistical strategy experience, strong CDISC knowledge, regulatory submission requirements, and current drug development trends.
- Excellent programming skills, including independently generating analysis output.
Nice to have
- R and/or SAS fluency; familiarity with applying AI/ML tools to statistical workflows.
- Experience evaluating external clinical data through due diligence, licensing, or M&A; track record of hiring, managing, and developing statisticians.
Tools
CDISC, R, SAS, AI, machine learning
AI focus
Identify opportunities for AI and machine learning to improve statistical workflows; familiarity with applying AI/ML tools to statistical workflows is a plus.
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