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London, United Kingdom | full time | Job ID:10350
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. If you are passionate about translating science into survival and thrive in a fast-paced, collaborative environment, we invite you to join our team.
Your main responsibilities are:
* 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
What you have to offer:
Educational Background:
* A PhD or Master’s degree in (Bio)Statistics, Mathematics, or equivalent
Professional Experience:
* 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
Technical Skills:
* 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
Addtional Skills:
* 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 the 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. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.
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At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.
Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encouragecreativity, and develop business strategies driven by our shared passion for advancing medicine.
Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.
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