- 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.
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Principal Biostatistician - India - ACL Digital
Description
Principal Biostatistician (10+ Years of Exp)
Location: Remote
Roles and Responsibilities:
