RESPONSIBILITIES

• Develop collaborative relationships and work effectively within the department, with external vendors and members of cross-functional teams.
• Effectively and independently program/troubleshoot/debug complex code.
• Understands software development methodologies and appropriately applies those methodologies to software development situations.
• Ensures priorities are aligned and communicates proactively and effectively around issues and risks and contributes to remediation.
• Provides comprehensive programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis.
• Drives the development and implementation of innovative strategies and technologies for flexible and global clinical trial programming.
• Reviews key planning documents to ensure they are clear, align with objectives, and address programming requirements.
• Supports development of unambiguous and robust programming specifications for internal and external programming work.
• Interacts with vendors regarding project standards, programming conventions/specifications and file transfers.
• Provides technical guidance to vendors supporting analysis and reporting work. Provides support for acceptance of vendor deliverables.
• Builds successful partnerships and seamless interfaces within the department and the broader research and development organization.
• Provides timely and effective communication to project team members, highlighting goals and priorities, ensuring work efforts parallel departmental objectives.
• Provides leadership for quality of deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices.
• Identifies opportunities for increased efficiency and consistency.
• Contributes to globalization, improvement and standardization of processes/standards/tools.
• Contributes to the technical evaluation of candidates and supports their successful integration.

REQUIREMENTS

• Graduate degree in statistics, mathematics, computer science or equivalent experience required.
• 6 + years clinical/statistical programming experience including supporting significant regulatory filings (e.g. NDA, BLA, MAA) required.
• Expert knowledge of the SAS Base and SAS Graph and working knowledge of common Stat module procedures required.
• Extensive knowledge of drug development process, clinical trial methodology, statistical concepts used in the analysis and submission of clinical data required..
• Extensive experience in statistical programming and developing computing strategies for statistical analysis &reporting required.
• Knowledge of industry practices and regulatory requirements required.

HOW TO APPLY