Performs preplanned statistical analyses, e.g. from the SAP or DPP, with supervision
Presents analysis results and interpretations to GBDS team.
Provides internal GBDS review of other SAPs, results, CSRs.
Knowledge of results outside of traditional statistical expertise in the clinical, regulatory and commercial environments and the impact the development team
Engages as a GBDS team member to learn the drug development process
Assists in development of presentations of analyses to key stakeholders
Knowledgeable of statistical methodology and how it might be appropriately applied in trial design and data analysis for clear, concise, high-quality results.
Knowledge of statistical / clinical trials methodology as it relates to clinical development
Understanding of data analysis planning, execution and delivery
Understanding of CDISC standards and implementation guides
Qualification & Experience
BS degree in Statistics or equivalent & ≥ 3 years of industry related experience OR
Master's degree in Statistics or equivalent & ≥ 1 year of industry related experience