- Contract Type
The biostatistician is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. Statisticians develop collaborative relationships and work effectively with the GBS Biostatistics Lead, the GBS Planning and Execution Lead, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team.
- Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis
- Communicates effectively with clinical and regulatory partners
- Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents
- Exercises cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted
- Compliant with Client Processes and SOPs, global and project standards, and responsible for quality of deliverables
- Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information
- Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles
- Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team.
- Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions
- Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.
- Significant academic training in statistics, biostatistics or relevant areas of study. PhD degree in statistics or biostatistics or Master’s degree with relevant experience required.
- Understanding of the application of biostatistics to medical/clinical trials data.
- Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals.
- Excellent verbal and written communications skills.
- Ability to be flexible and adapt quickly to the changing needs of the organization.
- Ability to organize multiple work assignments and establish priorities.
- Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization, and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.