Director, Biostatistics

Your Role
- Serve as a biostatistics expert for clinical programs
- Provide strategic input to optimize trial designs (early phase dose escalation; late phase registrational)
- Collaborate with internal/external CRO teams to plan and execute statistical deliverables
- Conduct statistical modeling and address statistical issues
- Contribute to clinical protocol development (author/review Statistics sections and apply statistical principles)
- Author/review statistical analysis plans (SAPs) and oversee tables/figures/listings and associated deliverables
- Review eCRF designs to ensure data meets statistical analysis requirements
- Provide statistical input for clinical documents
- Perform QC/QA of statistical deliverables, including validation of key results
- Perform ad hoc statistical analyses as needed
- Contribute to clinical study reports (statistical methods and interpretation)
- Support IND/NDA/MAA (or other regulatory) submissions, including thorough review of required components
- Address statistical questions/comments from FDA/EMA and IRB/ECs
- Support publications (manuscripts, posters, presentations)
- Lead biostatistics standardization and process improvement (templates/standards)
- Represent the company on statistical issues with external parties
- Support inspection readiness; develop advanced oncology trial design competencies

What You Bring (Qualifications)
- PhD in statistics or related; MS with relevant experience
- 10+ years’ pharma/biotech experience
- Oncology experience
- Clinical trial design, analysis, and reporting experience
- Experience with INDs/NDAs/MAAs or other regulatory submissions
- In-depth clinical trial statistical methods knowledge; FDA/EMA/ICH knowledge
- Proficient in SAS and R
- Experience with SDTM and ADaM
- Experience with CRO outsourced statistical services
- Ability to lead multiple studies; independent initiative; excellent written/oral communication