Director Data Standards And Statistical Programming

Overview

• Lead strategic initiatives for statistical programming standards and infrastructure development in a dynamic and innovative environment.
• Ensure compliance with regulatory requirements, industry standards, and internal quality processes for programming deliverables.
• Collaborate with cross-functional teams to drive innovation and efficiency in programming workflows.
• Oversee the creation and lifecycle management of global macros, reusable code libraries, and programming tools.
• Provide leadership and mentorship to a team of statistical programmers and standards specialists.
• Identify emerging technologies and best practices to enhance programming capabilities.
• Champion process improvements and standardization initiatives across the organization.
• Serve as a subject matter expert during audits and regulatory inspections.

Key Responsibilities & Duties

• Define and execute the vision for statistical programming standards aligned with organizational goals.
• Establish governance for global programming standards, tools, and processes.
• Ensure adherence to SDLC principles for programming tools and infrastructure components.
• Collaborate with IT to maintain robust, secure, and compliant programming environments.
• Oversee quality control processes for CRO deliverables and internal outputs.
• Align standards and infrastructure with clinical development needs through stakeholder collaboration.
• Manage resource allocation, training, and career development for team members.
• Influence organizational policies related to programming standards and infrastructure.

Job Requirements

• Bachelor's degree in a related discipline with extensive pharmaceutical/biotech statistical programming experience.
• Proficiency in SAS/Base, SAS/Stat, SAS/Macro; experience with R and Python is advantageous.
• Strong knowledge of CDISC standards, SDLC principles, and regulatory requirements.
• Demonstrated strategic thinking and ability to translate vision into actionable plans.
• Excellent leadership, communication, and collaboration skills.
• Experience authoring SOPs and work instructions for programming standards.
• Familiarity with oncology clinical trials is preferred.
• Ability to work on complex problems requiring innovative solutions and strategic analysis.