- Lead the statistical input for more than one disease indication, including review with Research and Development management.
- Actively contribute to global project and study teams as a core member
- Research and program statistical methodologies such as Survival Analysis, Bayesian approaches, Interim Analyses including Futility
- Be accountable and responsible for the statistical design, analysis, reporting and interpretation of Phase 1-4 clinical trials including biomarker analyses and integrated analyses across trials
- Contribute to the statistical design of studies, write the SAP and mock TFLs, contribute to the CSRs.
- Manage and review CRO deliverables
- Drive and oversee CDISC implementation for oncology trials.
- Partner with Data Management and SAS Programmers to ensure high quality clinical trials databases and analysis data sets
- Represents department in meetings with regulatory agencies and investigator.
- Builds/maintains a strong network of external statistical experts
Qualifications and Experience
- PhD or (MS) in Biostatistics or Statistics with a minimum of 6 (or 8) years of pharmaceutical, CRO or biotechnology industry experience
- Experience supporting oncology trials is required
- Demonstrated experience leading regulatory submissions across multiple trials and indications