Clinical Research

• **As a Senior Biostatistician, your responsibilities will include: **
• - 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

Senior Biostatistician – FSP

Regional Clinical Study Manager

Senior Biostatistician – FSP

Clinical Trial Manager – FSP

Biostatistician II – Client Dedicated

Senior Biostatistician