Statistical Programmer Consultant

Overview

• Collaborate on statistical programming tasks for clinical studies, ensuring compliance with industry standards and regulatory requirements.
• Develop and validate datasets adhering to CDISC SDTM and ADaM standards for submission readiness.
• Create and review specifications for analysis datasets to support statistical analysis and reporting.
• Independently program and validate tables, figures, and listings using advanced SAS techniques.
• Engage with cross-functional teams, including biostatistics and data management, to ensure project success.
• Provide technical expertise and input into documentation and programming tools development.
• Identify opportunities for process improvement and contribute to programming efficiency enhancements.
• Work remotely in a flexible and collaborative environment with potential for contract extension.

Key Responsibilities & Duties

• Conduct statistical programming activities across multiple clinical projects, ensuring high-quality deliverables.
• Review and annotate case report forms (CRFs) for SDTM mapping and compliance.
• Develop and validate SDTM and ADaM datasets adhering to CDISC standards.
• Write and review analysis dataset specifications to meet project requirements.
• Program and validate tables, figures, and listings using SAS software.
• Collaborate with biostatistics, data management, and cross-functional teams to achieve timelines.
• Provide technical input into documents created by other departments.
• Identify and support new utility tools to enhance efficiency and quality.

Job Requirements

• Bachelor’s degree in Statistics, Biostatistics, Computer Science, or Engineering; Master’s degree preferred.
• Minimum of 8 years of experience in biotech or pharmaceutical industry as a statistical programmer.
• Proficiency in CDISC SDTM and ADaM programming standards.
• Strong expertise in SAS programming for creating complex tables, listings, and figures.
• Experience with eCTD submissions to FDA, EMA, and PMDA regulatory bodies.
• Ability to create Define.xml files and reviewer’s guides for submissions.
• Excellent communication skills and ability to work independently under supervision.
• Remote work arrangement with potential for contract extension.