The biostatistician is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, preparation of regulatory submissions and publications. Statisticians develop collaborative relationships and work effectively with the Global Biometric Sciences (GBS) Lead, the GBS Planning and Execution Lead, statistical programmers, external partners, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team.
- Independently leads the development and execution of statistical aspects for multiple complex clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications.
- Leads portions of filing activities.
- Utilizes strong technical skills to address complex issues within a team.
- Assists GBS Lead in addressing regulatory questions and advisory committee preparations.
- Defends protocols and analysis plans at Protocol Review Committee reviews and provides independent reviews.
- Participant in continuous improvement initiatives.
- Demonstrates knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments and application within development teams.
- Effectively engages as a matrix team member on protocol or higher level project teams to act as a scientific and strategic partner in the drug development process.
- Presents summary data and analyses to key stakeholders and review committees in a clear, concise, complete and transparent manner that provide influence on key development decisions.
- Extensive technical knowledge of statistical methodology that is appropriately applied in trial design and data analysis for clear, concise, high-quality results.
- Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.