Work mode : Hybrid / Remote Location : Across India Experience - 6 yrs Looking for Immediate Joiner with Biomarker experience JOB DESCRIPTION: Key Responsibilities Provide statistical input for protocol development, study design, and sample size calculation Develop Statistical analysis Plan including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports. Collaborate with cross-functional teams including clinical, regulatory, medical writing, and data management Oversee production and quality control of randomization schedules Review case report forms and data validation guidelines to ensure quality and integrity of study data collection Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards Provide statistical input for Data Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) activities, including development of DSMB/DMC charters an...