Senior Statistical Analyst

Tata Consultancy Services; Cincinnati (OH); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Discretionary Annual Incentive

Comprehensive Medical Coverage

Maternal & Parental Leaves

401K Plan

Job summary

Tata Consultancy Services in Cincinnati, OH, is seeking a Statistical Programmer to program and validate ADaM and statistical analyses using SAS and R. You will generate TLFs for study reports, develop programming documentation, and ensure compliance with regulatory guidelines.

Collaborate with statisticians and study teams, lead standard macros, and support audits and submissions. Strong teamwork and communication skills are required.

Qualifications

• Bachelor's degree in Computer Science required.
• Proficiency in SAS and R for programming and validation of ADaM, TFL and analyses.
• Understanding of statistical methods and clinical research processes.
• Knowledge of CDISC standards and therapeutic areas is a plus.

Responsibilities

• Collaborate with statisticians to develop, review, and approve Statistical Programming Plans (SPP).
• Program and validate ADaM and statistical analyses using SAS/R.
• Generate tables, listings, and figures (TLFs) for clinical study reports and safety reports.
• Develop and maintain programming documentation and validation plans.
• Perform quality control on statistical programming deliverables.
• Support cross-functional teams with ad‑hoc data analyses and data visualization.
• Lead development of standard programming macros and tools to improve efficiency.
• Stay updated with regulatory guidelines and industry best practices.
• Lead audits, inspections, and regulatory submissions related to statistics programming.
• Provide programming support to study teams and publications.
• Complete tasks within agreed timelines and quality standards.
• Escalate issues to Team Lead and provide timely status updates.
• Coach and mentor new team members.

Skills

SAS programming

R programming

ADaM data standards

Statistical analyses

Education

Bachelor's degree in Computer Science

Tools

SAS

R

Job description

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.