Biostatistician II-III

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

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 Statistical Research Associate level II-III.

The Statistical Research Associate provides high intermediate-level 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 or formally supervise more junior SRAs as required. Conduct performance reviews of direct reports
• Perform other responsibilities as required

Minimum qualifications:

• MS or PhD degree in Statistics or Biostatistics or related field with demonstrated work experience.
• SRA II A minimum 2yrs of work experience is required.
• SRA III 3 years of related work experience is required.
• Proficiency with the SAS or R (as required by specific team/project)
• Demonstrated knowledge of general statistical practice within clinical trials
• Thorough understanding of statistical programming process and best practices
• Functional understanding of GCP and regulatory requirements
• Proven track record of collaboration with internal colleagues
• Strong oral and written communication skills

 

Preferred qualifications:

• 4+ years of relevant work experience
• Demonstrated specialized knowledge of statistical practice within network specialization
• Proven track record of collaboration with external collaborators

 

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

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.