Head of Biostatistics

🔬 Head of Biostatistics [AI-Driven Biotech]

Locations: New York, NY;
Boston, MA; (Hybrid) San Francisco, CA;
Raleigh, NC (Remote) 📍

Impact: Shape the statistical strategy powering AI-accelerated drug development, across a multi-asset clinical pipeline backed by top pharma 🎯

Benefits: Unlimited PTO, Equity, Medical, Vision and Dental Benefits, Pet Insurance, Disability Benefits, One Medical family cover, to name a few... 🌟

This is a next-generation biotech built around an AI-first vision for drug development. Backed by major pharma and top-tier investors, the company combines advanced machine learning, LLM-driven discovery, and deep clinical expertise to accelerate the end-to-end development cycle.

They have multiple assets in the clinic (Phase I–III) across several therapeutic areas and a proven platform identifying and acquiring additional candidates. With FDA-aligned ML systems already in place, the organization is scaling rapidly and investing heavily in clinical and statistical innovation.

With continued pipeline expansion and growing strategic partnerships, the company is building out its biometrics leadership. You will lead Biostatistics strategy, shape clinical development frameworks, and drive innovative approaches that fully leverage AI and Bayesian methodologies.

You’ll partner closely with Clinical Development, Data Science, and Regulatory leaders to modernize trial strategy and execution and help define what AI-enabled clinical development looks like at scale.

• Lead and grow the Biostatistics function, fostering scientific rigor and innovation
• Drive statistical strategy across multiple clinical programs, from early-phase design through pivotal studies
• Develop and implement novel trial designs, including simulation-based and Bayesian approaches
• Bring forward new ways to integrate AI and automation into statistical workflows and decision-making
• Influence clinical development plans (endpoints, patient populations, inclusion/exclusion criteria, key assumptions)
• Guide regulatory interactions and represent Biostatistics with FDA/EMA
• Establish best-practice statistical processes, tools, and SOPs
• Partner with and oversee CRO and external statistical vendors
• Support diligence and evaluation of potential new drug assets

• Demonstrated leadership in Biostatistics within biotech/pharma
• Proven ability to design and deliver clinical trials across Phases I–III
• Deep expertise in Bayesian methods, adaptive design, and simulation-based planning
• Experience working in an AI-driven drug development environment
• Strong understanding of regulatory pathways, submissions, and health-authority interactions
• Ability to translate complex statistical thinking into clear, strategic guidance for cross-functional teams
• Strategic mindset paired with hands-on technical depth and willingness to roll up sleeves
• Strong communication and reasoning skills, with a track record influencing high-stakes decisions
• Experience building or shaping a Biostatistics function, ideally in a scaling biotech

• Publications or industry leadership in statistical innovation
• Familiarity with RWE-driven evidence generation or model-informed drug development

Reports to the VP of Biometrics
, who oversees Biostats, Clinical Programming, and Data Management.

• True AI-first biotech with real clinical assets
• Lead a core function, reporting to the VP Biometrics
• Work in a highly technical, mission-aligned team
• Opportunity to redefine how biostatistics and AI intersect in drug development