Director Biostatistics - Oncology

We are seeking a highly skilled and experienced Director of Biostatistics to provide statistical leadership and support for clinical trials and programs, aligning with company objectives and BioNTech ́s UK Oxford research hub. This role is pivotal in driving statistical excellence in oncology clinical development, ensuring high-quality deliverables, and fostering innovation in statistical methodologies.

Requirements

• Provide statistical support for priority BioNTech global trials and Oxford Research projects, ensuring alignment with clinical and organizational goals
• Represent Statistics in cross-functional clinical study teams and projects, taking accountability for all statistical aspects
• Oversee and provide statistical guidance on trials within a program or platform, ensuring quality and compliance
• Train and mentor colleagues as a Subject Matter Expert (SME) in specialized topics such as Diagnostics, Biomarker, PK/PD, PRO, AI, HTA, or RWE/Epidemiology
• Contribute to clinical development plans, study protocols, reports, regulatory submissions, and publications, ensuring accuracy and scientific rigor
• Lead the development of statistical analysis plans, perform sample size calculations, and validate analysis results
• Oversee outsourced statistical CRO activities, ensuring timely and high-quality deliverables
• Collaborate with Clinical Data Managers to ensure data quality standards are met and provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications
• Support health authority meetings, including planning, document preparation, and response development
• Drive initiatives to improve standards, processes, and infrastructure within the Biostatistics function

Benefits

• Competitive remuneration package
• Variety of benefits in support of our diverse employee base