Job Description

We are working closely with a global biotechnology company for a Director of Biostatistics to play a strategic leadership role within their oncology development organization. This individual will lead statistical strategy and oversight across global clinical trials spanning early- to late-stage development, with a strong focus on regulatory readiness, data integrity, and scientific excellence.

Key Responsibilities

• Provide strategic direction and technical oversight for statistical aspects of oncology clinical trials (Phases I–IV)
• Lead the development of statistical analysis plans, trial designs, and data interpretation strategies
• Contribute to the development and validation of integrated safety and efficacy datasets (ISS/ISE)
• Serve as the statistical representative in interactions with health authorities, ethics committees, and internal governance boards
• Evaluate and manage CROs and other external vendors to ensure high-quality deliverables and compliance with timelines and budgets
• Support initiatives to standardize best practices, CDISC implementation, and innovative statistical approaches

Candidate Profile

• PhD in Biostatistics, Statistics, or related field and +10 years experience within industry
• Direct experience in oncology clinical trials with strong focus on late-stage development
• Expertise in regulatory submissions and interaction with FDA/EU health authorities
• Strong working knowledge of CDISC standards (SDTM, ADaM) and statistical tools (e.g., SAS, EAST, nQuery)
• Experience managing or closely overseeing CROs and external partners
• Confident communicator with the ability to present complex data to senior stakeholders and cross-functional leadership
• On-site in King of Prussia is required

If you are interested please apply or reach out via eireann.evans@meetlifesciences.com !

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