- Perform Lead Biostatiscian role on medium complecity studies, providing statistical oversight and attending relevant project meetings
- Perform project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management
- Preparation of Statistical Analysis Plans (including mock TFL shells) for medium complexity studies
- Perform complex statistical analyses, quality check statistical analyses developed by other statisticians
- Conduct overall statistical review of TFLs for complex studies prior to client delivery
- Review CRF and other study specific specifications and plans
- May perform sample size calculation of simple studies under the supervision of more senior statistical staff
- Develop the statistical sections of the protocol for simple to medium complexity studies under the supervision of a statistical consultant
- Provide statistical input and review of the Clinical Study Reports for medium complexity studies
- Preparation and review of randomization specifications and dummy schedules
- Mentor of biostatisticians within project activities; assigned tasks related to the development of staff within the department
- Present and share knowledge at team meetings and/or at monthly seminars
- Represent the department during project-driven client audits.
- Master's degree, equivalent, or higher in Biostatistics or related field.
- 5-8 years of experience or an equivalent combination of education or experience to successfully perform the key responsibilities of the job
- Ability to program in one or more statistical software packages (SAS) used to conduct statisticial analyses. SAS proficiency including using of a variety of statisticial procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis.
- Ability to effectively communicate statistical concepts
- A good knowledge of the overall clinical trial process
- Experience in the preparation of Statistical Analysis Plans, analysis, reporting, etc.
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