Sr. Biostatistician_Clinpharm

Job Summary

Sr. Biostatistician_Clinpharm

Job Responsibilities

Senior Biostatistician (5-8 Years)

Key Responsibilities

• Review Statistical Analysis Plans (SAPs) in alignment with protocols and regulatory requirements.
• Develop mock shells, define analysis datasets, and support randomization activities.
• Perform protocol reviews and contribute statistical inputs during study design and execution.
• Review Clinical Study Reports (CSRs) and ensure accuracy and consistency of statistical outputs.
• Support Phase I studies including PK/PD analyses, biomarker evaluations, and clinical pharmacology assessments (Phase 1A, 1B, and 2A).
• Validate Tables, Listings, and Figures (TFLs) and ensure compliance with quality standards.
• Work with CDISC standards (SDTM/ADaM) and collaborate with statistical programming teams.
• Apply SAS for statistical analyses and data review activities.

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