Biostatistician (AD - Director Level)

EPM Scientific are currently partnered with an innovative Biotechnology company advancing a portfolio of early- and late-phase Oncology programmes. They are urgently seeking a Senior Statistical Consultant / Associate Director (Biostatistics), reporting to the Senior Director Biostatistics, to support their expanding Biometrics team. The role will focus on providing strategic and hands-on statistical leadership across complex oncology studies, including early-phase trial design. See a summary of the role below: 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.
• Proven ability to operate both strategically and hands-on across clinical development activities.
• Prior sponsor-side experience preferred, with demonstrated stability and progression in previous roles.

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