Senior Statistical Analyst

About the role

This position is responsible for developing, reviewing, and approving Statistical Programming Plans (SPP) and implementing SAPs to create ADaM data specifications. The role involves programming and validating statistical analyses, generating clinical study reports, and collaborating with cross-functional teams.

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.
• 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.
• 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.

Qualifications

• Bachelor of Computer Science