Principal Statistician in Ernakulam, भारत

Lead statistician role at a global CRO involving statistical analysis plan development, clinical trial design support, and biostatistical consultancy for clinical research projects. Requires advanced degree with substantial statistical experience and expertise in regulatory standards.

Responsibilities

• Lead development and implementation of Statistical Analysis Plans and study protocols
• Design clinical trials including statistical methodologies, randomization, and analysis frameworks
• Develop and validate SAS programs for derived datasets, SDTM/ADaM compliance, and statistical reporting
• Manage statistical support across one or more projects, ensuring sponsor requirements are met
• Mentor statisticians on methodological issues and provide consultancy to internal and external stakeholders

Requirements

• BSc with 8 years, MSc with 6 years, or PhD with 4 years relevant experience
• Expert-level project statistician with proven statistical leadership capabilities
• Broad experience across clinical research phases with regulatory knowledge
• Advanced SAS proficiency; other statistical software knowledge beneficial
• Strong English communication skills, both written and oral
• Time management and ability to manage multiple concurrent projects
• Experience in team environments across multiple therapeutic areas