Biostatistician (Clinical Trials)

Updated: December 4, 2018
Job ID: 213620
Status: Full-Time
Regular/Temporary: Regular
Location: Rockville, MD, United States

Join the HJF Team!

HJF is seeking a Biostatistician to support the Center for Neuroscience and Regenerative Medicine (CNRM) Clinical Trials Unit (CTU) located in Bethesda / Rockville MD. HJF provides scientific, technical and programmatic support services for CNRM.

The CNRM was established as a collaborative intramural federal program involving the U.S. Department of Defense and the National Institutes of Health, developed to bring together the expertise of clinicians and scientists across disciplines to catalyze innovative approaches to traumatic brain injury (TBI) research. Diverse study protocols include observational and interventional studies collecting imaging data, psychological and neurocognitive assessments, biomarkers, and genetic data. This interdisciplinary position offers excellent potential for research collaboration.

Responsibilities will include the provision of statistical support throughout the clinical trial lifecycle, providing support and advising CNRM investigators from study design and development through study execution and analysis. The Biostatistician will report to the CNRM Chief Medical Officer.

Responsibilities:

  1. Provides statistical support to CNRM investigators throughout the research lifecycle, including proposal preparation, protocol development, interim analyses, and publications and presentations.
  2. Participates in design of experiments for fully randomized designs as well as more complex designs involving limits to randomization, optimization techniques, familiarity with design diagnostics (statistical power, reductions in factor correlations, variance inflation factors).
  3. Contribute to the development of Statistical Analysis Plan (SAP), Data Management Plan (DMP), develop table figures and listings, statistical programs, clinical study reports.
  4. Ensure that study data is created in a usable format for dissemination, catalogued and managed efficiently according to Good Clinical Research Practices.
  5. Work with leadership, program staff, CNRM statisticians, and program investigators to achieve the goals of the research program.
  6. Performs other duties as required.

Required Knowledge, Skills, and Abilities:  Demonstrate statistical knowledge with expertise in supporting clinical studies that includes descriptive statistics, sample size estimation, power calculation, estimation of treatment effects, outlier analysis, randomization schedules; expertise using statistical packages (e.g., SAS, R, STATA) and conducting simulations; ability to communicate effectively; ability to make effective presentations and publish; excellent interpersonal skills; experience in neuroscience research a plus. Experience with design and simulations of Bayesian adaptive clinical trial designs preferred.

Minimum Education/Training Requirements:  Master's degree in Statistics

Minimum Experience:  4 to 6 years of related experience

Physical Capabilities:  Extended periods of sitting

Supervisory Responsibilities/Controls:  May provide guidance to junior biostatisticians

Work Environment:  Office or laboratory environment

Background:  US Citizenship required; Eligibility to obtain and Common Access Card (CAC) background. This position may require eligibility to obtain a Department of Defense Secret Clearance.

HJF is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

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