Senior Biostatistician

Project role: Senior Biostatistician

Work experience: 8+ years

Work Mode: homebased

Required skills: 8+ years relevant biostatistics experience

Role Overview:

Lead statistical activities for clinical studies, including protocol input, sample size calculations, SAP development, analysis specifications, and interpretation of results. Guide study teams, interact with clients, oversee timelines, and ensure high‑quality statistical deliverables. Provide mentorship to junior statisticians.

Key Responsibilities:

• Develop/Review statistical sections of protocols, CRFs, SAPs, and shells
• Program and QC analysis datasets, tables, listings, and figures
• Review database design, validation checks, and support data issue resolution
• Lead study-level biostatistics activities and manage timelines & resources
• Prepare statistical outputs for CSRs and support regulatory submissions
• Identify project risks, propose solutions, and support budget/scope management
• Mentor junior team members and contribute to knowledge sharing

Requirements:

• Bachelor's/Master's/PhD in Biostatistics or related field
• 8+ years relevant biostatistics experience
• Strong SAS programming skills; familiarity with nQuery a plus
• Solid understanding of GCP, ICH, CDISC (SDTM/ADaM)
• Experience leading biostat activities on clinical studies
• Excellent communication, documentation, and problem‑solving skills