Senior Statistical Analyst

Role: Senior Statistical Analyst

Location: Cincinnati, OH/Chicago, IL/New York City, NY/Jersey City, NJ

Duration: Full Time (FTE)

Required Skillsets:

• Proficiency in SAS / R programming languages to Program and validate ADaM, TFL and statistical analyses
• Proficiency in using statistical software and programming tools
• Understanding of statistical methods, data analysis techniques, and clinical research processes.
• Advance knowledge of CDISC standards and therapeutic area (Oncology, Immunology, Neuroscience etc.)
• Strong attention to detail and quality Focus
• Problem-solving skills (Ability to identify and troubleshoot programming issues)
• Effective communication skills (both written and verbal)
• Ability to interact professionally with statisticians, study teams, and external partners
• Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines.

Key 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.