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 Manager, Biostatistician 
Ref No.: 16-00714
Location: Woodcliff lake, New Jersey
Manager, Biostatistician
NEURO
  • 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;
  • Work with 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 programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables. Perform post-hoc statistical analyses as needed.
  • May work on submission teams as a statistician and/or a programmer.
  • Generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies
  • Will serve as lead Statistician on complex trials and across multiple studies.
  • Project work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans.
  • Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs and SWPs to improve quality, efficiency and timeliness of work processes.

QUALIFICATIONS NEEDED:
  • Must have a MS in Biostatistics/Statistics with at least 10 years of experience or a PhD in Biostatistics/ Statistics with at least 7 years of experience in the pharmaceutical, CRO or biotech industry.
  • Strong SAS programming skills.
  • Neuro experience is required.
  • Ability to effectively work on multiple projects
  • Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
  • Applies good judgment and leads problem solving within the team