Associate Director Statistical Programmer

Overview

• Lead statistical programming efforts, ensuring high-quality deliverables and compliance with regulatory standards in a dynamic environment.
• Utilize advanced SAS programming techniques to develop macros, datasets, and graphical summaries for clinical data analysis.
• Collaborate with biostatisticians and clinical data teams to establish robust data collection and reporting standards.
• Ensure adherence to CDISC standards, creating datasets in SDTM and ADaM formats for regulatory submissions.
• Provide oversight and quality control for deliverables from external partners, ensuring consistency and accuracy.
• Contribute to departmental infrastructure development and troubleshoot technical challenges effectively.
• Support team development through training and mentoring, fostering a culture of excellence.
• Manage multiple projects and ad-hoc requests, ensuring timely and efficient execution.

Key Responsibilities & Duties

• Develop and maintain global macros and standard programs, adhering to Software Development Lifecycle methodologies.
• Coordinate data transfers and deliverables with clinical data management and biostatistics teams.
• Identify resource needs and oversee statistical programming activities to ensure project success.
• Ensure programming outputs meet high-quality standards through rigorous validation and defensive programming techniques.
• Monitor and guide external partners in dataset development, ensuring adherence to documentation standards.
• Produce study datasets and programs aligned with CDISC standards for regulatory submissions.
• Communicate effectively with cross-functional teams to align on project timelines and deliverables.
• Provide leadership in training and mentoring team members, enhancing departmental capabilities.

Job Requirements

• Bachelor's degree in a relevant field with 8+ years of experience; advanced degrees preferred.
• Proficiency in SAS programming, including SAS/Base, SAS/Stat, SAS/Macros, and familiarity with UNIX systems.
• Extensive experience with CDISC standards and regulatory submission processes.
• Strong analytical skills and ability to manage complex programming tasks effectively.
• Demonstrated leadership and team management capabilities in a professional setting.
• Commitment to regulatory compliance and adherence to company policies and guidelines.
• Experience in oncology clinical trials and NDA submissions is highly desirable.
• Ability to prioritize and manage multiple tasks in a fast-paced environment.