• Senior Statistical Programmer

    Job Locations US-WA-Seattle
    Job ID
    2018-1245
    Category
    Clinical & Medical Affairs
  • Overview

    The Senior Statistical Programmer is a member of the Biometrics team and will provide statistical programming in support of the analysis and reporting of data from ongoing and legacy clinical trials.  This position works closely with team-members from Biostatistics, Data Management, Safety and Clinical Operations on various clinical projects and activities.

    Responsibilities

    • The Senior Statistical Programmer will provide principal programming support for a large ongoing clinical trial in the active surveillance setting in prostate cancer, ProVent. 
    • Lead the programming activities across a variety of projects including: the analysis and reporting of clinical trials data, supporting Health Economic and Outcomes Research activities, and support biomarker identification.
    • Participate in the development of and compliance with Standard Operating Procedures (SOPs), policies and guidelines.
    • Participate in the development and implementation of programming standards meeting regulatory requirements across all studies.
    • Participate in developing detailed statistical analysis plans and implementing those plans during the development of materials and outputs including specifications for those materials.
    • Work closely with project statisticians and other team members to produce analyses and summaries of the clinical trial data.
    • Develop SAS programs to generate data sets, summary tables, listings and figures, patient profiles and other materials, as required, for understanding, analyzing, and presenting clinical trials and research data.
    • Develop standard macros and/or tools in SAS for data analysis and reporting.
    • Participate in cross functional teams supporting the conduct of clinical trials and provide the statistical programming perspective on those teams.
    • Communicate to management and project team members on project status including any resource issues that may impact timelines and deliverables.

     

    Qualifications

    • BA/MS degree in a quantitative or scientific field.
    • At least 7 years of clinical trials experience in a pharmaceutical, biotech, CRO setting or other clinical research setting.
    • Understanding of industry standards, medical terminology, and clinical trials methodologies.
    • Experience acting as a lead or principal programmer for the statistical programming for all phases of clinical trials and managing the activities of a statistical programming CROs or one or more programmers.
    • Experience programming with BASE SAS, SAS Analytics, SAS Macros, and the Output Delivery System.
    • Ability to work on-site at the company’s Seattle office.
    • Strong organizational and communication skills and an ability to work independently

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