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

A PhD or Master’s degree in (Bio)Statistics, Mathematics, or equivalent
A minimum of 5 years in the academic statistics, and/or the pharmaceutical industry and/or CRO
Proven experience in 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

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base.

Director, Biostatistics – Oncology

Key skills