Senior Director, Biostatistics
About The Position
As a Senior Director, Biostatistics, you will play a pivotal role in shaping the statistical strategy for our clinical programs, driving data-driven decisions that are integral to BioNTech’s mission of advancing global health. Your expertise will contribute to the development of innovative therapies, helping us address unmet medical needs in oncology and beyond. You will work within a collaborative environment, partnering with multidisciplinary teams to ensure statistical excellence across all phases of clinical trials. This is your opportunity to lead impactful projects while mentoring talented professionals and influencing regulatory submissions.
Requirements
- Advanced degree (PhD or Master’s) in (Bio)Statistics, Mathematics, or equivalent field
- Extensive experience (12+ years for PhD; 15+ years for Master's) in the pharmaceutical industry or CRO
- Proven leadership experience managing biostatistics teams and collaborating in matrix organizations
- Expertise in planning, conducting, and analyzing oncology trials across phases I-IV
- Proficiency in SAS/R software and sample size calculation tools like EAST or NQuery
- Strong knowledge of advanced statistical methods (e.g., adaptive design or Bayesian approaches)
- Experience in leading to answer health authority questions (FDA, EMA) and leading in statistics on regulatory submissions, including developing ISE/ISS packages.
- Exceptional analytical skills with the ability to develop realistic plans and communicate complex analyses effectively
Responsibilities
- Represent Biostatistics in cross-functional clinical study teams and provide expert guidance on statistical aspects
- Lead statistical strategies for trials within a platform or portfolio, ensuring high-quality deliverables
- Develop statistical analysis plans, perform sample size calculations, and validate analysis results
- Oversee outsourced statistical CRO activities while ensuring quality and timely delivery
- Provide statistical insights into clinical development plans, protocols, reports, regulatory submissions, and publications
- Support health authority meetings by preparing documents and responses as required
- Mentor and manage biostatistics staff while fostering talent development
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
