Director Biostatics - Oncology

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London, United Kingdom | Full-time | Job

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.

• 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 TLF specifications
• Support health authority meetings, including planning, document preparation, and response development
• Drive initiatives to improve standards, processes, and infrastructure within the Biostatistics function

• A PhD or Master’s degree in (Bio)
  Statistics, Mathematics, or equivalent

• Minimum of 5 years in academic statistics, pharmaceutical industry or CRO
• Proven experience planning, conducting and analyzing oncology trials across all phases (I–IV), including scientific publications
• Expertise in supervising outsourced activities and developing outsourcing strategies
• Experience leading responses to health authority questions (FDA, EMA) and regulatory submissions, including ISE/ISS package development

• Advanced knowledge of clinical development, study designs and statistical methods (adaptive design and/or Bayesian methods are a plus)
• Proficiency in statistical analysis software (SAS and/or R) and sample size calculation tools (e.g., EAST, NQuery)
• Deep understanding of specialized topics such as Diagnostics, Biomarker, PK/PD, PRO, AI, HTA, or RWE/Epidemiology is a plus

• Excellent analytical skills with the ability to develop realistic plans, recommendations and risk mitigation strategies
• Strong communication, including the ability to express complex analyses in clear language and an excellent command of written and spoken English
• Teamwork spirit and ability to build strong relationships with key stakeholders

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. Competitive remuneration packages are determined by role, location and qualifications.

Apply by sending your CV, s, degree certificates, professional certificates, motivation letter and contact details via our online form. Only online submissions will be considered. Background checks will be conducted as part of the recruitment process.

We are looking forward receiving your application.