Biostatistician

We are seeking a Biostatistician to help with clinical study analysis and medical writing; power analysis and trial design in support of FDA filings; and cross-departmental statistical support for our clinical, lab, and informatics teams. This role will not be boring! Success will lead to numerous publications, successful FDA interactions, and career growth opportunities. On-the-job learning and a desire to say ‘yes’ to new things are expected.

PRIMARY RESPONSIBILITIES:

  • Participate in the design of clinical trials and case report forms, and provide sample size calculations and statistical methodology for study protocols
  • Analyze data for registrational and non-registrational prospective and retrospective studies, write statistical reports for integration into clinical study reports, and describe your work in drafting clinical abstracts and manuscripts
  • Perform data review and database clean-up, perform data analyses, and review clinical study reports for registrational submissions
  • Work collaboratively with others on statistical issues in Pre-IDE submissions and in response to FDA queries after submissions until the final market approval
  • Statistical support for lab team, mainly experiment design
  • Statistical support for informatics team, mainly exploratory data analysis

QUALIFICATIONS:

  • BA/BS degree in relevant field and at least five years’ industry experience. MS/PhD a plus but not required.
  • Prior experience working with clinical data and/or clinical trials analysis, including mixed models and random effects models
  • Experience using R
  • History of manuscript/abstract publications
  • Background in Bayesian statistics is a plus

KNOWLEDGE, SKILLS, AND ABILITIES:

  • Excellent verbal and written communication
  • Good data visualization skills
  • Knowledge of infectious diseases or emergency or ICU medicine a plus but not required
  • Excited to ‘wear many hats’, and self-motivated to take on new challenges
  • Track record of success in a deadline-driven and multi-task environment
  • Well organized and detailed oriented
  • Ability to work in diverse team settings with a top-notch scientific team

SALARY AND CLASSIFICATION:

  • Compensation: Competitive and commensurate with experience; includes equity package.

HOW TO APPLY: Please forward a cover letter and resume to: jobs [at] inflammatix [dot] com

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2018-12-04T19:16:54+00:00