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 one or more clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications.
- Participates in protocols and analysis plans reviews.
- Participates in continuous improvement initiatives.
- Knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments with demonstrated application within development teams.
- Engages as a matrix team member on protocol teams as a scientific partner in the drug development process.
- Ability to present summary data and analyses to key stakeholders in a clear, concise, complete and transparent manner.
- Possesses technical knowledge of statistical methodology and ability to appropriately apply it 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.