Senior Statistical Analyst

Job Title: Senior Statistical Analyst

Location: Cincinnati OH (Onsite)

Job Type: Full Time

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.