Associate Director, Statistical Programming (Park Ridge, NJ)
-Work closely with clinicians, programmers, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinate internal resource utilization for publication and generate activities metrics for management review.
-Work with the clinical study team on study design, development and/or review of clinical study protocols.
-Develop and/or review statistical analysis plans, including Table/listing/figure shells, and final study report for clinical studies; perform post-hoc statistical analyses as needed.
-Work with the project statistician and clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality.
-Oversee CRO programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, ensure the quality of CRO deliverables.
-CDISC expertise is a must
-Submission, ISS, and ISE expertise
-Advance knowledge of Regulatory & Compliance Requirements for Biostatistics processes
-Solid leadership skills, including management of people resources, FTEs, Contractors, and/or CRO vendors within a matrixed environment
-Experience in multiple TA is desired, Neurology strong preferred.
-Experience in clinical development statistical programming methods and processes in industry setting required.
-MS in relevant field and 8+ years of statistical programming experience or equivalent.