to support the design, analysis, and reporting of clinical trial data. The role involves statistical programming (SAS/R), ensuring data accuracy, and compliance with GCP and regulatory guidelines.
Key Responsibilities:
Support the design and implementation of statistical analyses for clinical trial data, including safety, efficacy, exploratory endpoints, and other related outcomes.
Collaborate with the Data Management team to prepare, clean, and validate clinical trial datasets, ensuring accuracy and integrity.
Assist junior statisticians in the design and planning of clinical studies, including sample size estimation, randomization strategies, and preparation of Statistical Analysis Plans (SAPs).
Perform data integrity checks to identify and resolve inconsistencies, discrepancies, or errors in datasets.
Provide statistical input to study protocols, particularly in relation to sample size justification and analysis methodologies.
Maintain comprehensive documentation of statistical methodologies, programming codes, data processing steps, and assumptions used in analyses.
Contribute to the development of statistical sections of Clinical Study Reports (CSRs), regulatory submissions, and other study-related documentation.
Create high-quality visual outputs (tables, listings, figures, charts, and graphs) for inclusion in reports, regulatory dossiers, and presentations to stakeholders.
Ensure all statistical analyses comply with Good Clinical Practice (GCP), ICH guidelines, regulatory requirements (FDA, EMA), and internal Standard Operating Procedures (SOPs).
Collaborate with clinical project coordinators, medical writers, clinical monitors, and other cross-functional teams to ensure statistical requirements are met throughout the study lifecycle.
Provide on-demand statistical support for ongoing clinical trials, troubleshooting issues related to data analysis and interpretation.
Job Type: Full-time
Pay: ?20,000.00 - ?30,000.00 per month
Benefits:
Food provided
Health insurance
Paid sick time
Provident Fund
Education:
Master's (Required)
Experience:
Statistician: 1 year (Required)
Language:
English (Required)
Kannada (Required)
Location:
Bengaluru, Karnataka (Required)
Work Location: Remote