Forum Topic Statistics
  • Conversation: Manager - Biostatistician

    • March 16, 2017 4:25 PM GMT
    • Manager - Biostatistician

      Hi All,I do have below requirement which is for our Direct Client. Please let me know your are interested.Title: Manager -
      Location: Woodcliff Lake, NJ
      Duration: Long Term (12+
      ·         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
      ·         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 teamThanks,
      Kishore Rao,
      Phone : (732) 227-1772 Ext- 413 
      Fax: (732) 909 2358  / Email:

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