Description
The Biostatistician is responsible for the design, development and evaluation of the technical and statistical infrastructure. This individual will also be responsible for the conduct and evaluation of clinical trials, including the coordination of all related areas/activities.Key Responsibilities:
- Prepare statistical section of study protocol and any necessary amendments
- Perform exploratory analysis of past studies and conduct examination of literature for sample size estimation
- Prepare randomization plan and related documentation, as well as SAP and TFLs design including in-text tables and figures
- Provide input to CSR development
- Provide input to CDISC Programming Specification and Statistical Programming Specification (CPS and SPS) development, and review, (e-)CRFs, monitoring, data management, data QC and data validation plans
- Leads team in the areas of experimental design, protocol development, statistical analysis plans and statistical analysis to meet project objectives
- Create and collate statistical section of clinical study reports, INDs, NDAs, and annual reports
- Serve as a contributing member of project teams with Clinical Data Managers, Statistical Programmers, and other MDG management responsible for meeting study objectives
- Independently determine the best methods and techniques in design of complex analysis in support of project objectives
Position Qualifications:
Minimum Qualifications:
- Ph.D. with 3+ years of industry experience
- Master's degree with 5+ years of industry experience
To find out more about Real please visit www.realstaffing.com