Associate Director Of Statistical Programming

Associate Director of Statistical Programming Overview

• The Associate Director of Statistical Programming will lead programming efforts for clinical trial data analysis and regulatory submission deliverables.
• This role combines technical expertise and project management to ensure high-quality programming outputs.
• Contribute to automation and innovation within the programming group to enhance efficiency and effectiveness.
• Collaborate with cross-functional teams to define deliverables and align expectations.
• Operate in a hybrid work environment, balancing office and remote responsibilities.
• Support the client’s mission of advancing neuroscience through statistical programming excellence.
• Provide mentorship to junior staff, fostering growth and adherence to programming standards.
• Ensure compliance with CDISC standards and regulatory requirements for clinical trial data.

Associate Director of Statistical Programming Key Responsibilities & Duties

• Lead statistical programming activities for study and project-level deliverables.
• Develop and validate SAS programs for CDISC-compliant datasets and regulatory submission outputs.
• Design and implement innovative automation tools for statistical programming.
• Collaborate with biostatistics, clinical operations, and regulatory teams to ensure project alignment.
• Provide technical guidance and project management to ensure operational excellence.
• Mentor junior programmers on standards, practices, and project management.
• Support exploratory analysis and ad-hoc reporting needs.
• Maintain programming environments for secure and efficient data analysis.

Associate Director of Statistical Programming Job Requirements

• Master of Science degree in a relevant field is required.
• Minimum of 8 years of experience in pharmaceutical, biotech, or CRO settings.
• Expertise in SAS programming, including BASE SAS, SAS/STAT, SAS/GRAPH, and SAS MACROS.
• Extensive knowledge of CDISC SDTM and ADaM standards.
• Proficiency in additional programming languages like R and Python is preferred.
• Experience with FDA electronic submissions and GCP/ICH guidelines.
• Strong organizational, problem-solving, and project management skills.
• Neuroscience experience and SAS LSAF expertise are advantageous.