Support Lead ST on the following tasks:
Develops statistical analysis plans and reporting specifications for clinical studies.
- Develops and describes appropriate statistical techniques for the analysis of data in a statistical analysis plan.
- Works with other statisticians on statistical methodology, study design, therapeutic area details, and data analysis.
- Design appropriate shells and specifications for outputs.
Performs statistical analyses and interprets results for clinical studies.
- Develops or QCs analysis programs to implement techniques described in the statistical analysis plan.
- Approves final database for freeze/lock.
- Assesses model assumptions for statistical analyses.
- Works with programmers, writers, and clinicians to coordinate data summarization and analysis activities, including summary statistics, tabulations, graphics, analysis output, and raw data listings.
- Develops statistical reports and statistical sections of clinical study reports.
Contributes statistical expertise to project teams for the analysis, and reporting of clinical studies.
- Provides input into the preparation and review of clinical study protocols.
- Creates dummy and final randomization schemes for clinical studies.
- Participates in the development and review of CRFs, data edit specifications, and critical variable lists.
Maintains, develops, and shares knowledge of company and industry procedures and methodologies.
- Performs billable work in accordance with WuXi CDS’s policies, procedures, and SOPs.
- Maintains solid knowledge of drug development process.
- Maintains solid knowledge of SAS procedures and good programming practices.
- Continues statistical training on new methods and techniques via self-study, internal training and courses, and external conferences and courses.
- Develops knowledge of FDA and EMEA guidelines and requirements for reporting of clinical trials data.