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Senior Principal Statistical Programmer

Company: The American College of Radiation Oncology
Location: Bothell
Posted on: February 23, 2021

Job Description:

DescriptionDescription

Summary:--

Oversee statistical programming activities for multiple Phase I-IV clinical studies or an entire product or group. Coordinate all tasks and participants, both within Statistical Programming and among cross-functional stakeholders, and drive progress utilizing best practices in order to ensure budgets, timelines, and performance requirements are met. Ensure that project and analysis level deliverables are completed on time, in high quality, and in accordance with company, industry, and regulatory requirements. Fulfill a leadership role in enhancing departmental processes and standards. Recognized as a go-to SME across the entire programming function in several technical or procedural areas.

Principal Responsibilities:

  • Lead all statistical programming activities across multiple studies, filings, projects, or an entire product, and be responsible for the accuracy, completeness, quality, and timeliness of statistical deliverables
  • Decide on and implement study, filing, project, and product-level specifications for assigned projects in compliance with company, regulatory, and industry standards
  • Develop and test programs towards high-quality datasets, tables, listings, and figures within set timelines in accordance with company and regulatory standards and requirements
  • Review and provide feedback on deliverables from other clinical groups including but not limited to statistical analysis plans; table, listing, and figure shells; data management plans; data transfer plans; and case report forms
  • Independently specify and implement complex analysis algorithms per statistical analysis plans
  • Proactively recommend continuous improvements to departmental processes, standards, and utilities. Support departmental initiatives in an advisory capacity that facilitate standards, infrastructure, and process enhancements across Biometrics, or lead such initiatives and decide on their design and implementation
  • Engage cross-functional study and project teams to clarify requirements and specifications, update others on progress, and convey data irregularities
  • Represent Statistical Programming as an advisor or decision-maker in collaborative cross-functional settings
  • Train and mentor new and junior programmers in a project management capacity
    --Qualifications:
    • 10+ years (BS) or 8+ (MS/PhD) of SAS programming experience in the Biotechnology, Pharmaceutical, Medical Device, or Healthcare industries
    • 7+ years of experience in performing statistical programming using SAS-- for creating and testing analysis datasets, tables, listings, and figures for Phase I-IV clinical studies
    • 5+ years of experience in managing statistical programming projects
    • 4+ years of experience in writing SAS macros
    • Expert knowledge and understanding of SAS-- programming concepts and skills
    • Demonstrated proactivity and strong attention to detail
    • Experience in Oncology studies; experience with integrations and e-submissions a strong plus
    • Experience in leading statistical programming activities in support of global regulatory filings
    • Excellent understanding of CDISC SDTM and ADaM standards--
      Education:
      • BS, MS, or PhD
        As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com .

        Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

        #LI-EK1

        Job Information
        • Job ID: 55699510
        • Location:
          Bothell, Washington, United States
        • Position Title: Senior Principal Statistical Programmer Seagen is a global biotechnology company dedicated to developing revolutionary therapies with real impact.Our visionImproving the lives of people with cancer through innovative targeted therapiesOur missionTo discover, develop, and commercialize transformative cancer medicines to make a meaningful difference in people's lives Senior Specialist Commercial Training &... 2001 6th Ave, Suite 2700 Seattle, Washington 98121 (206) 956-3650

Keywords: The American College of Radiation Oncology, Seattle , Senior Principal Statistical Programmer, IT / Software / Systems , Bothell, Washington

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