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.