Principal Progr-Stat Progr

Principal Programmer, Statistical Programming Northern, NJ (Onsite or Remote) Responsibilities Perform SAS data processes and analysis programming. Work with Statistician and Statistical programmer to assure results are consistent with expectations, and quality control procedures are followed. Lead the development and delivery of training. Act as primary contact to ensure company standards are implemented in all studies. Work collaboratively to meet study deliverables and timelines for statistical data analysis and reporting. Plan and carefully document differences between programming results between program developer and Statistical QC programmer. Provide programming support on ISS/ISE and post-submission activities. Provide flexible and rapid responses to programming requests. Ensure consistency and adherence to standards within the project. Confirm that tracking sheets are current for projects and results are consistent with earlier generated results. Maintain up-to-date study documentation. Identify opportunities to improve methodology and provide practical solutions for problems. Develop, program, test, and maintain computer validation/edit checks in SAS. Validate peer programming. Provide technical expertise and support to the Data Management team. Routinely interface with cross-functional team members. Participate in regular team meetings and provide input when appropriate. Participate in the development of clinical programming SOPs and optimize clinical programming processes from study start-up to database lock. Manage project priorities and timelines. Review programming activities and costs in contracts. Direct responsibility for supervising and training junior clinical programmers. Qualifications B.S. degree or higher in programming or statistics. Minimum of 5 years of SAS experience in pharmaceutical or equivalent. Understanding of GCP, ICH, and FDA guidelines and regulations applicable to clinical research. Knowledge of CDISC standards and industry best practices. Strong SAS programming, macro development, and SAS graph skills. Good knowledge of statistical terminology, clinical data structure, clinical tests, medical terminology, regulatory standards, and protocol designs. Excellent oral and written communication skills for cross-site and cross-function collaboration. Dependable, motivated, focused, and detail-oriented. Ability to take direction as needed and work independently on projects when necessary. Capable of managing time effectively and adhering to timelines and project schedules. Working knowledge of SAS modules and utilities. Ability to develop routines using the SAS Macro Language. Understanding of biotech industry regulatory requirements. Ability to use Microsoft Office tools (Word, Excel, PowerPoint). #J-18808-Ljbffr Clark Davis Associates, Inc