Senior Statistical Analyst

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.

• 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.

$120,000 – 140,000 a year.

• 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.

Bachelor of Computer Science.