Principal Biostatistician

Principal Biostatistician (10+ Years of Exp)

Location: Remote

Roles and Responsibilities:

• Accountable for the Production of High-Quality Deliverables and Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken.
• Maintain effective customer relationships, driving statistical discussions, providing support and/or guidance for statistical activities.
• Plans and documents timelines, forecasts resource needs, suggests work may be out of scope.
• Performs sample-size calculations, generates randomization lists and writes statistical methodology sections for study protocols.
• Provides broad statistical support including protocol development and clinical trial design.
• Authors or performs quality control review (QC) of Statistical Analysis Plan (SAP) and Shells.
• Reviews protocol to ensure statistical integrity and optimal study design.
• Reviews statistical analysis plans, derived datasets, tables, listings and figures.
• Coordinates and leads project team, interacts with clients as key statistical contact.
• Provides input into and reviews CSR and other summary reports.
• Prepares or reviews Statistical Analysis Report (SAR).
• Perform the unblinded lead statistician role if needed.
• Review the proposals/budgets at a study level and contribute to request for proposals (RFP), shall be expected to present at bid defences.