Principal/Associate Director, Application Programming

The Principal/Associate Director of Application Programming is responsible for leading the group that provides systems support and software/program development to aid the conduct and analysis of Phase II “" IV clinical trials and regulatory submissions. Responsibilities: - Maintain SAS Programming environment in a validated state ensuring conformity with relevant regulatory requirements - Ensure that other software installations used by the BDM Department are properly validated - Serve as the lead SAS administrator supervising access, data transfers, and setting - Designs statistical programming practices including necessary SOPs - Writes and validates standard macros. Maintains global macro library. - Develop, maintain, and implement data standards for clinical projects - Ensures compliance with applicable standards and practices of statistical work performed - Provide training for statistical programmers - Responsible for ensuring quality, implementation and timeliness of standards and deliverables - Evaluate and recommend new system processes and/or technologies which offer opportunities to improve business processes - Develop, mentor, and supervise application programming staff - Ensure that application programming resources are well planned for based on staff availability, priorities and timelines - Obtain user requirements and ensure customer support for new applications - Other duties as assigned or as business needs require Primary Outcomes: - SAS programming environment that facilitates the rapid high quality analyses of clinical trials and preparation of regulatory submission - Effective management and prioritization of application programming projects and resources Qualifications: Education Required: Bachelor's degree in statistics, computer science, or other relevant field Preferred Education: Master of Science or PhD in statistics, computer science, or other relevant field Required Experience: - SAS Programming including global SAS macro development - Production of Tables, Figures, and Listings for clinical trials - Preparation of datasets and programs for regulatory submission - Minimum of 8 years of pharmaceutical or related industry experience Preferred Experience - Installation and Development of SAS programming environment Functional Knowledge Requirements: - Software Development Life Cycle - Computer system validation - CDISC - 21CFR11 requirements To Apply for this position, please CLICK HERE