Senior Statistical Analyst

Tata Consultancy Services is a leading technology and consulting company, and they are seeking a Senior Statistical Analyst. The role involves collaborating with statisticians to develop statistical programming plans and validating statistical analyses, ensuring adherence to industry standards and regulatory requirements.

Responsibilities:

• Collaborate with statisticians to develop, review, and approve Statistical Programming Plans (SPP).  Implement Statistical Analysis Plans (SAP) and SPP to create ADaM data specifications
• Program and validate ADaM and statistical analyses using programming languages (e.g., SAS, R), ensuring adherence to established standards and guidelines
• Generate tables, listings, and figures (TLFs) for clinical study reports, safety reports, and other deliverables, ensuring accuracy, consistency, and adherence to regulatory requirements
• Develop and maintain programming documentation, such as annotated program code, programming specifications, and validation plans
• Perform quality control checks on statistical programming deliverables to ensure accuracy, consistency, and adherence to programming standards
• Collaborate with cross-functional teams to support ad hoc data analyses, data visualization, and exploratory analyses as needed
• Ability to lead the development and implementation of standard programming macros, utilities, and tools to improve efficiency and consistency in programming tasks
• Stay updated with industry best practices, regulatory guidelines, and emerging technologies in statistical programming and data analysis
• Lead the planning and execution of statistical programming-related audits, inspections, and regulatory submissions, ensuring compliance with relevant regulations and guidelines
• Collaborate with statisticians and study teams to provide programming support, address data-related queries, and contribute to study-related publications
• Performs assigned task(s) in accordance with customer requirements within agreed timelines and Quality
• Escalates unresolved issues appropriately to Team Lead /Project Lead. Tracks and follows up on all issues raised. Provides timely status updates. Proactively highlight risk
• Coach/Mentor/Train new team members and line function as per requirement