Head of Biostatistics
i-Pharm Consulting, WorkFromHome, MA, United States
Overview
Head of Biostatistics (AI-Driven Biotech)
Locations: New York, NY; Boston, MA; San Francisco, CA; Raleigh, NC (Hybrid)
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...
About
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.
What You’ll Do
- 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
Requirements
- 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
Nice to Have
- Publications or industry leadership in statistical innovation
- Familiarity with RWE-driven evidence generation or model-informed drug development
Reporting Line
Reports to the VP of Biometrics , who oversees Biostats, Clinical Programming, and Data Management.
Why It’s Special
- 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