Senior Statistical Analyst

Job Description

Required skill sets:

• 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
• Advanced knowledge of CDISC standards and therapeutic areas (Oncology, Immunology, Neuroscience, etc.)
• Strong attention to detail and quality focus
• Problem‑solving skills (ability to identify and troubleshoot programming issues)
• Effective communication skills (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 regulatory compliance.
• 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 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 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 expectations.
• 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 lead the line function as required.

$120,000 – $140,000 per 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, 401(k) plan, performance bonus, college fund, student loan refinancing

– Bachelor of Computer Science (minimum)