Biostatistician

Biostatistician II statistical analyses for clinical research studies as outlined in statistical analysis plans, including creating statistical graphics and verifying randomization codes. They prepare statistical sections of protocols, including sample size calculations, annotate shell data displays, and provide specifications for the structure, content, and algorithms of status and analysis datasets. They perform and oversee quality control (QC) of data displays with inferential statistics.

Statisticians report to the Biostatistics Manager.

QUALIFICATIONS FOR ESSENTIAL FUNCTIONS

1. Develop, validate, and maintain SAS programs to create analysis datasets, tables, listings, and figures (TLFs) as specified in statistical analysis plans.

1. Design and verify randomization codes to support clinical trial integrity.

1. Prepare statistical sections of protocols, including sample size calculations, and annotate shell data displays.

1. Provide specifications for the structure, content, and algorithms of status and analysis datasets.

1. Perform and oversee quality control (QC) of data displays and analysis datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM).

1. Conduct independent validation of datasets created by other programmers or statisticians.

1. Maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, and programming/QC documentation.

1. Manage electronic project directories to ensure organization and accessibility of deliverables.

1. Mentor and guide junior programmers, providing training on SAS programming and clinical data standard