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The role of the Senior Principal Statistician is to perform statistical activities for assigned Phase I-IV clinical studies from protocol development to final study report and provide statistical leadership for the Biostatistics, Statistical Programming, and Data Management study team.
1. Review protocol and prepare statistical sections, including sample size calculation.
2. Review CRF, database design, edit check specifications, and external data specifications.
3. Prepare detailed statistical analysis plan and table/figure/listing shells.
4. Work closely with Statistical Programmers in test runs, identify data quality issues for key efficacy and safety variables.
5. Work closely with Statistical Programmers in the final execution of statistical analyses.
6. Review final study report.
7. Provide statistical leadership for the Biostatistics, Statistical Programming, and Data Management study team.
8. Represent Biostatistics on study team.
Education PhD or MS degree in Statistics, Biostatistics or equivalent required. ( PhD is preferred .)
A minimum of 4 years of pharmaceutical statistics experience is required- post PhD (or a minimum of 7 years of experience with a MS degree in Statistics or Biostatistics). EOE Statement
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