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

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.

Senior Director, Biostatistics

Key skills