This position plays a functional lead role in the design, analysis, and reporting of clinical studies. Writes statistical analysis plans, performs statistical analyses, contributes to study reports, and interacts with other study team members and clients on study set up and conduct, including timelines and financial oversight.
Develops statistical analysis plans and reporting specifications for simple to moderate 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 simple to moderate 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 design, analysis, and reporting of simple to moderate clinical studies.
- Serves as primary functional representative on project teams.
- 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.
- Works with the project manager and functional manager to determine resource projections and project schedules.
- Visits clients to discuss statistical issues.
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.
- MS degree with 3 years of experience or PhD degree in statistics or biostatistics with 2 years of experience.
- Demonstrated expertise in multiple statistical areas.
- Demonstrated ability to plan, implement, and monitor the statistical processes for clinical studies.
- Excellent written and oral communication skills; Read, write and speak English.
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