The Biostatistician I is responsible for providing statistical support, including study design, sample size and protocol development in support of clinical projects. Prepares statistical analysis plans, generates statistical summary tables and performs database integration for more comprehensive analyses.
Responsibilities
- Prepares statistical analysis plans, timelines for statistical project management and performs and interprets basic and complex analyses. Utilizes knowledge of statistics and medical understanding to propose and perform additional analyses when appropriate.
- Documents analyses, creates summaries and presents written and verbal results to requestors.
- Writes statistical text for study reports and clinical publications. Prepares analysis plans and methods used for incorporation in abstracts, manuscripts and grants.
- Identifies potential data problems from analytic queries and takes appropriate actions to guide the resolution process.
- Collaborates with principal investigators, sponsors and external representatives to ensure that project results and conclusions are presented accurately and without bias and to jointly achieve objectives and timelines.
- Provides quality review on statistical analysis plan to ensure consistency with protocol and adequacy to meet objectives defined in protocol.
- Adheres to standard operating procedures of the functional department as they apply to documentation and validation of clinical research statistics.
- Provides consultation to the clinical research project team on statistical issues related to the project.
- Collaborates with statistical programmers that support clinical projects to identify potential data problems from analytic queries and to take appropriate action to guide the resolution process.
- Performs other related duties.
Qualifications
- Masters degree in biostatistics, computational biology or related.
- 1-2 years of biostatistics or related experience in clinical research preferred
- Advanced level of experience in SAS, R or similar application
