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Job Details

Irvine, CA  Posted: 1/15/2020


Exciting Opportunity as a Biostatistician with a Leading Pharma company! If you are a match, we look forward to reviewing your application! 
Location: Irvine, CA option to work from home
  • Serve as a study Biostatistician for multiple clinical studies
  • Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
  • Author statistical analysis plans for studies and/or ISS/ISEs, and author/edit shells for tables, figures and listings
  • Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses
  • Provide statistical input to data monitoring committee (DMC) charters, project management plans, and other study-level documents
  • Work with statistical programmers or CROs to generate tables, figures and listings
  • Support ongoing safety review and DMC review of the clinical development program/study teams
  • Perform ad hoc and exploratory statistical analyses as needed
  • Contribute to clinical study reports, including authoring of statistical sections, interpretation of the study results, and QC of the results in the reports.
  • Support regulatory submissions as needed
  • Support the preparation of publications, including manuscripts, posters and oral presentations
  • Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs
  • MS in Biostatistics or equivalent with at least 5 years of relevant clinical trial experience or PhD in Biostatistics or equivalent with at least 3 years of relevant clinical trial experience
  • Knowledge of statistical methods for clinical trials
  • Proficient in statistical programming (SAS is required, and R is a plus)
  • Good communication skills and ability to work with cross-functional study teams
  • Ability to multi-task in an extremely fast-paced environment with changing priorities

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