Senior Statistician

Job Summary:

We are seeking a proactive male Senior Statistician with 1–2 years of experience 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

Application Deadline: 30/08/2025
Expected Start Date: 20/08/2025