Job Description 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. 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. Perform assigned tasks in accordance with customer requirements within agreed timelines and quality standards. Escalate unresolved issues appropriately to Team Lead/Project Lead, track and follow up on all issues raised, provide timely status updates, and proactively highlight risk. Coach, mentor, and train new team members, and line function as per requirement. Salary Range $120,000 – 140,000 a year. TCS Employee Benefits Summary Discretionary Annual Incentive. Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. Family Support: Maternal & Parental Leaves. Insurance Options: Auto & Home Insurance, Identity Theft Protection. Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement. Time Off: Vacation, Time Off, Sick Leave & Holidays. Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing. Qualifications Bachelor of Computer Science. #J-18808-Ljbffr
Senior Statistical Analyst • Cincinnati, OH, United States
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