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Accountabilities
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 from 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 and reviews 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 WuXiPRA¡¯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.
•        Trains and mentors new or junior statisticians on statistical methods and WuXiPRA procedures.
•        Develops knowledge of FDA and EMEA guidelines and requirements for reporting of clinical trials data.

Qualifications
        MS degree with 3 years of experiencewithin the clinical trials or pharmaceutical industry or Fresh PhD degree in statistics or biostatistics
        Demonstrated expertise in multiple and complex 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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