Biostatistician (AD - Director Level)

Role Overview

Start date: ASAP
Location: US, Remote (Open to highly qualified candidates in Europe)
Contract Type: Freelance / Consultant - 1 FTE, 12 Months Contract
Language: English
Project: Early-phase oncology trials, complex & platform study designs

Key Responsibilities

• Lead statistical strategy and design for early-phase oncology clinical trials, with input into later-phase development where required.
• Provide hands-on statistical input across study protocols, SAPs, and key regulatory deliverables.
• Collaborate cross-functionally with clinical, regulatory, and data teams to optimise study design and ensure scientific rigor.
• Support and potentially lead complex trial methodologies, including adaptive or platform trial designs.
• Act as a senior statistical representative in internal and external meetings, providing strategic guidance to stakeholders.
• Oversee statistical deliverables and ensure quality, timelines, and regulatory compliance are maintained.

Requirements

• Advanced degree (MSc or PhD preferred) in Statistics, Biostatistics, or related quantitative field.
• Extensive experience in biostatistics within pharma/biotech, including leadership of oncology studies (AD level or above preferred).
• Strong expertise in early-phase clinical trial design and execution within Oncology.
• Deep expertise in statistical modelling (especially Bayesian).
• Experience with complex trial designs (e.g., adaptive, platform trials) highly desirable.
• Prior sponsor-side experience preferred, with demonstrated stability and progression in previous roles.