Director Biostatics - Oncology

BioNTech; Oxford; On-site; GBP 80,000 - 110,000; Full time

Job summary

A leading biopharmaceutical company in Oxford is seeking a Director of Biostatistics. This vital role will lead statistical support for oncology clinical trials, oversee data quality, and mentor teams. Candidates should possess a PhD or Master's in Statistics with 5+ years of relevant experience. Proficiency in SAS and R is essential, and experience with regulatory submissions is preferred. We offer competitive pay and a supportive work culture focused on innovation and excellence.

Benefits

Competitive remuneration packages

Supportive work environment

Diverse employee benefits

Qualifications

• Minimum 5 years of experience in academic statistics or pharmaceutical industry.
• Experience in oncology trials across all phases (I-IV).
• Proven experience in statistical methodology and regulatory submissions.

Responsibilities

• Provide statistical support for clinical trials and projects.
• Lead development of statistical analysis plans.
• Collaborate with Clinical Data Managers to ensure data quality.

Skills

Statistical analysis

Clinical trial planning

Communication

Analytical skills

Education

PhD or Master’s degree in (Bio)Statistics or Mathematics

Tools

SAS

R

EAST

NQuery

Job description

Overview

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.

Responsibilities

• 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

Qualifications

• 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

Benefits

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 are 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.

Equal Opportunity Statement

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer.

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. 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.