Senior Biostatistician (Park Ridge, NJ)

Primary Responsibilities:
-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, and ensure the quality of CRO deliverables
-May work with the Health Outcome team on the design/analysis/validation of projects
-May work on submission teams as a statistician and/or a programmer. Act as lead Statistician on complex trials and across multiple studies
-Act as a lead representative of the of the biostatistics department on project teams

-MS in Biostatistics/Statistics with at least 10-12 years of experience or a PhD in Biostatistics/ Statistics with at least 6 years of experience in the pharmaceutical, CRO or biotech industry
-Strong SAS programming skills. – at least 3-5 years
-Oncology experience is highly preferred
-Good technical writing skills
-Good communication skills (verbal and written)
-Strong teamwork ability/commitment and individual initiative

Type: Long-term Contract