Biostatistician II

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

• Develop, validate, and maintain SAS programs to create analysis datasets, tables, listings, and figures (TLFs) as specified in statistical analysis plans.
• Design and verify randomization codes to support clinical trial integrity.
• Prepare statistical sections of protocols, including sample size calculations, and annotate shell data displays.
• Provide specifications for the structure, content, and algorithms of status and analysis datasets.
• Perform and oversee quality control (QC) of data displays and analysis datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM).
• Conduct independent validation of datasets created by other programmers or statisticians.
• Maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, and programming/QC documentation.
• Manage electronic project directories to ensure organization and accessibility of deliverables.
• Mentor and guide junior programmers, providing training on SAS programming and clinical data standards.

• Master's degree in Statistics or equivalent combination of education and experience (e.g., a Bachelor's degree and at least 3 years of industry experience as a biostatistician) required.
• A minimum of 3 years of experience as a statistician is required for the Senior Statistician position.
• A minimum of 1 year of supervisory approval is required for the non-Senior Statistician level.
• Proficient in SAS and similar clinical data analysis software.

• Mid-Senior level

• Full-time

• Research, Analyst, and Information Technology