Biostatistician- Future Roles (India)

📋 Description

• • Provides end-to-end statistical support across clinical projects, from protocol development through Clinical Study Report (CSR) preparation.
• • Prepares Statistical Analysis Plans (SAPs), including creation of mock-up tables, listings, and figures for sponsor review and approval.
• • Contributes to the statistical design of clinical protocols, including development of randomization schedules and input into clinical study reports.
• • Coordinates and supervises activities of biostatistics and statistical programming teams to ensure timely, high-quality deliverables.
• • Reviews and validates programming specifications for analysis datasets, tables, listings, and figures.
• • Evaluates SAS annotated case report forms (CRFs), database designs, and study documentation to ensure alignment with protocol requirements and data capture integrity.
• • Conducts verification and quality control checks on all statistical deliverables to ensure consistency with SAPs and approved specifications.
• • Serves as the biostatistics representative on cross-functional project teams, actively contributing to meetings and collaborating with other departments.
• • Manages multiple project timelines, prioritizes work based on management directives, and proactively communicates delays or resource constraints.
• • Monitors study milestones and ensures adherence to project deliverable schedules; escalates out-of-scope tasks to management.
• • Provides statistical programming support as needed to meet project demands.
• • Participates in Data Safety Monitoring Board (DSMB) and Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician.
• • Leads integrated analyses and may represent the sponsor at regulatory agency meetings to defend statistical findings.
• • Ensures full compliance with company SOPs, work instructions, and regulatory guidelines including ICH standards.
• • Maintains comprehensive, organized, and inspection-ready documentation for all statistical activities and quality control records.
• • Supports business development through contribution to proposals, budget estimates, and sponsor bid defense meetings.
• • Mentors and coaches junior biostatistics staff to enhance team capability and knowledge transfer.
• • Performs additional duties as assigned, demonstrating flexibility and collaboration to meet evolving business needs.
• • Minimal travel may be required to support project or client needs.