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Senior Program Manager, Biostatistics

Company: ICON Clinical Research
Location: Topeka
Posted on: January 18, 2023

Job Description:

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.ICON has an exciting opportunity for a Senior Program Manager, Biostatistics to join our team.Location: (home-based OR office-based)

  • United States
  • CanadaOverview of the role:The Senior Program Manager, Biostatistics will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies of high complexity, and/or of high value with high impact for the organization. Also responsible for planning, monitoring, organizing, and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget to required quality, and maintain consistency across studies.
    • Biostatistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design
    • Review project database structures, edit checks, and data management coding conventions
    • Preparation of statistical analysis plans (SAP) including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports
    • Statistical analysis, Interpretation of data and reporting of results
    • Writing of the statistical methods sections of integrated study reports; reviews draft integrated study reports
    • Supports responses to regulatory questions on the design the design of the program, and any labelling claims following submission
    • The program of studies will typically lead to a regulatory submission and be for one of ICONs Strategic Clients.To be successful, you will need:
      • M.S. or Ph.D. degree in statistics, biostatistics, or related field (required)
      • 10+ years of relevant experience with M.S. OR 8+ years of relevant experience with Ph.D. (with at least 6-8 years of experience in the pharmaceutical industry)
      • Excellent verbal and written communication skills
      • In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas
      • Excellent knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must
      • Prior experience interacting with sponsor/clients
      • Experience leading Phase II and/or Phase III studies
      • Oncology experience is preferred, but not requiredBenefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. Thats why we are committed to developing our employees in a continuous learning culture one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.#LI-REMOTE #LI-JW1

Keywords: ICON Clinical Research, Topeka , Senior Program Manager, Biostatistics, Executive , Topeka, Kansas

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