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
Solid 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
📌 Senior Biostatistician (Maharashtra)
🏢 IQVIA India
📍 Maharashtra
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