Review study protocols and write statistical sections Conduct sample size and power calculations Generate randomization schedules Review case report forms to ensure appropriate data collection Review edit checks algorithm to ensure data quality for statistical analyses Participate in study team operations and timeline discussion Provide solutions to clinical operation and data management for issues that potentially impact data analyses Assist review and provide input to statistical analysis plans that are written by the 3rd party Prepare statistical analysis plans Prepare mock tables, figures, and listings Review programming specifications and work with statistical analysts/programmers to prepare CDISC compliant SDTM and ADaM datasets Conduct inferential statistical analyses and check model adequacy of statistical analyses Perform statistical validation/quality control on analyses generated by statistical analysts/programmers Conduct ad-hoc analyses and data mining Write statistical reports for results interpretation if needed Participate in clinical results interpretation meetings Work with medical writers to assist with clinical study reports preparation Work with project managers to ensure timely and high quality delivery of analysis packages

Qualifications Master’s or Doctoral degree in statistics or biostatistics Experience Master’s degree with 1-4 years or Doctoral degree with 0-2 years of relevant experience in statistical analyses Skills Good understanding in statistical concepts and methods Working knowledge of SAS and/or R Good interpersonal and communication skills