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Sr. Statistical Programmer

Buffalo, NY 14203

Posted: 11/09/2018 Job Category: Clinical: Biometrics Job Number: 2084

Provide Statistical Programming Support for Clinical Data Analysis and Submission.

Job Responsibilities:
  • This role is expected to contribute to the quality of data analysis and reporting deliverables for phase I to III clinical trials.
  • Provide programming support for the clinical study team by generating and maintaining patient profiles, tables, listings, figures and other types of outputs
  • Create annotated CRFs, mapping specifications and datasets per SDTM standards
  • Review analysis data specifications and create ADaM analysis datasets per Statistical Analysis Plan and ADaM data standards
  • Review Table/Figure/Listing shells for Clinical Study Report and produce tables, figures and listings accordingly
  • Perform program validation for external vendors and/or internal staff, as appropriate
  • Ensure that each statistical reporting deliverable has necessary and sufficient documentation as required by the company’ s SOPs

Required Education & Qualifications:
  • Bachelor’ s degree in Biostatistics, Statistics, or Relevant Fields required; Master’ s degree preferred
  • 1 to 3 years of experience in statistical data reporting for clinical studies
  • Strong SAS programming skills
  • Knowledge in creation of CDISC SDTM and ADaM data structures
  • Have strong verbal and written communication skills in English
  • Prior experience in therapeutic area of Oncology is preferred
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