Biostatistician

Summary:

In this role, you will support a clinical study team on statistical matters to ensure that studies are conducted in line with planned analyses. You will work under the guidance of senior staff, assisting in all relevant statistical tasks throughout the study's lifecycle.

Responsibilities:

• Collaborate with senior staff in the preparation of study protocols and amendments, including performing sample size calculations and drafting statistical methodology sections.
• Review case report forms (CRFs), providing comments and feedback.
• Develop statistical analysis plans (SAPs) and provide definitions/documentation to the programming team for derived variables needed for Tables, Figures, and Listings (TFLs).
• Perform statistical analysis according to the SAP, validate analysis programs, review TFLs, and prepare statistical methods and results sections for clinical study reports (CSRs). Support study result interpretation and guide the CSR through review and approval processes.
• Participate in project-related activities, including the preparation of BLA submissions, and oversee CRO deliverables for outsourced studies.

Qualifications:

• Master’s Degree in a related field.
• 2+ years of relevant experience.