• Providing statistical support to clinical studies • Participating in the development of study protocols, including participation in study design discussions and sample size calculations • Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications • Performing statistical analyses and interpreting statistical results • Preparing clinical study reports, including integrated summaries for submissions • Utilizing your strong communication skills to present and explain the methodology and consequences of decisions • Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions. • Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros • Participate in the development of CRFs, edit check specifications, and data validation plans • Provide review and/or author data transfer specifications for external vendor data • Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals • Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices