TheStatistical 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 130 employees and is currently managing over 40 active phase I 6 III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Statistical Research Associate II/III to provide intermediate-level statistical support in the planning, operations, monitoring, analytic, and exploratory stages of clinical trials and research.

May include some or all of the following:

• Collaborate with PhD statisticians/epidemiologists, Statistical Research Associates (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 or lead 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, Reviewers Guides).
• Generate written summaries for use in customized statistical lab reports.
• Participate in or lead 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 more junior SRAs as required. May conduct performance reviews of direct reports.
• Perform other responsibilities as required.

MINIMUM QUALIFICATIONS:

Statistical Research Associate II

• Master's degree in Biostatistics or Statistics.
• Minimum of one year of related experience.
• Background in statistical computing.
• Proficiency with the SAS or R (as required by specific team/project).

Statistical Research Associate III

All minimum requirements of the Associate II, plus:

• MS or PhD degree in Statistics or Biostatistics or related field with demonstrated work experience.
• A minimum of 3 years of related work experience is required.
• 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.

PREFERRED QUALIFICATIONS:

Statistical Research Associate 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.
• Proven track record of collaboration with internal colleagues.
• Strong oral and written communication skills.

Statistical Research Associate III

• 4+ years of relevant work experience.
• Demonstrated specialized knowledge of statistical practice within network specialization.
• Proven track record of collaboration with external collaborators.
• Proven track record of collaboration with internal colleagues.
• Strong oral and written communication skills.

Statistical Research Associate II: The annual base salary range for this position is from $84,490 to $126,714, and pay offered will be based on experience and qualifications.

Statistical Research Associate III: The annual base salary range for this position is from $97,822 to $146,682, and pay offered will be based on experience and qualifications.

Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.

Fred Hutchinson Cancer Center offers employees access to a retirement savings plan, an employee assistance program, paid sick leave (1 hour for every 30 hours worked), and prorated paid holidays (up to 11 days per year).