Principal / Lead Biostatistician

About the role

We are looking for a Principal / Lead Biostatistician to own statistical strategy and deliver regulatory‑ready outputs for our innovative clinical data platform. The role is hands‑on, senior‑level and sits at the intersection of biostatistics, product development and AI‑enabled data solutions.

Key responsibilities

• Lead study design, sample‑size calculations and overall statistical strategy for multiple clinical programs.
• Develop, review and approve statistical analysis plans (SAPs) and submission‑ready deliverables.
• Oversee creation, validation and maintenance of SDTM, ADaM datasets and TLFs.
• Build reproducible, R‑based analysis pipelines and ensure best‑practice coding standards.
• Collaborate with Product and Technology teams to define AI‑driven platform capabilities.
• Act as the senior statistical authority across projects, guiding junior staff and interfacing with regulatory agencies.

Required profile

• Post‑graduate qualification in Biostatistics, Statistics or a related discipline.
• Minimum 8 years of experience in clinical research or biostatistics, covering the full trial lifecycle.
• Hands‑on experience with SDTM, ADaM, TLFs and R.
• Familiarity with FDA, EMA, MHRA, SAHPRA or similar regulatory environments.
• Ability to thrive in a fast‑paced, entrepreneurial setting.

Required skills

• SDTM
• ADaM
• R programming
• Pinnacle 21 (or equivalent validation tools)
• Certara (or equivalent modeling tools)