Biostatistician II-III

Job ID
22869
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Clinical Research Support Services

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.


At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.


The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Biostatistician II-III.

Responsibilities

The Biostatistician provides statistical support in the planning, operations, monitoring, analytic, and exploratory stages of clinical trials and research. Job duties may include some or all of the following:

  • Collaborate with PhD statisticians/epidemiologists, SRAs, laboratory scientists, laboratory data managers, and other subject-matter experts to provide statistical support for clinical studies and research projects or laboratory data and analyses including statistical considerations and planning (power and sample size calculations), randomization lists, consultation, study data analyses, and written summaries and tables of results for use in study reports - for example, Data and Safety Monitoring Boards or other interim review meetings, scientific abstracts and manuscripts, and/or tables in support of a Clinical Study Report for submission
  • Contribute to and review study documents including protocol drafts, statistical analysis plans, case report forms, and other documents as required
  • Collaborate with data management and operations in the development of quality assurance procedures for on-going data collection, cleaning and analysis - such as establishing edit checks, or HIV endpoint verification
  • Participate in verification of standard reports prepared by programmers or other team members
  • Apply and adhere to CDISC data standards and guidelines where required in the production of analysis datasets and reports; assist in the production of supporting CDISC documentation for submissions (Define.xml, Reviewer’s Guides)
  • Generate written summaries for use in customized statistical lab reports
  • Participate in protocol team conference calls and meetings, organizational meetings, interim data review meetings, scientific meetings, regional meetings and internal team meetings as required
  • Maintain functional understanding of standard policies and procedures and complete required training in a timely manner; Contribute to the development and maintenance of standard procedures and related quality documents
  • Participate in internal project initiatives which may include developing new tools and processes, evaluating new statistical software packages, or exploring other value-added team activities
  • Represent SCHARP and the data analytics unit at professional meetings
  • Mentor junior SRAs as required
  • Perform other responsibilities as required

Qualifications

Minimum qualifications

  • MS or PhD degree in Statistics or Biostatistics or related field with demonstrated work experience
  • Biostatistician II:  A minimum of 1 year of related work experience is required
  • Biostatistician III: A minimum of 3 years of related work experience is required
  • Proficiency with the SAS or R (as required by specific team/project)
  • Functional understanding of GCP and regulatory requirements
  • Proven track record of collaboration with internal colleagues
  • Strong oral and written communication skills

 

Preferred Qualifications 

  • Biostatistician II
    • 2+ years of related work experience
    • Demonstrated elementary knowledge of statistical practice within clinical trials
    • Functional understanding of statistical programming process and best practices
  • Biostatistician III
    • 4+ years of relevant work experience
    • Demonstrated specialized knowledge of statistical practice within network specialization
    • Proven track record of collaboration with external collaborators

 

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Our Commitment to Diversity

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.

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