Senior Biostatistician (FSP + Remote)

Responsibilities

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

Qualifications

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: