Principal Biostatistician

4 weeks ago


delhi, India ACL Digital Full time
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.

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