Clinical Scientist, Endpoints/Outcomes

Location
Boulder, Colorado
Salary
Commensurate with experience
Posted
Nov 16, 2018
Required Education
Masters Degree/MBA
Position Type
Full time

Miragen Therapeutics (NASDAQ: MGEN) is a publicly traded clinical-stage biopharmaceutical company discovering and developing proprietary RNA-targeted therapeutics with a specific focus on microRNAs and their roles in diseases where there is a high unmet medical need.

Our growing Boulder-based organization is seeking a Clinical Scientist, Endpoints to provide oversight of all clinical trials efficacy endpoints. Primary responsibilities include:

  • Work across all clinical and translational programs reaching the clinic.
  • Research and propose best technique for endpoint collection
  • Organize and conduct training of site evaluators on performance/expectations for clinical endpoints
  • Assure PD and efficacy data are reliably collected in a systematic way and transferred in a timely fashion.
  • Monitor clinical efficacy data in real time to prevent missing data and unusable data.
  • Analyze data and prepare presentations for company’s needs.
  • Conduct remediation measures in a timely fashion when data is poor quality.
  • Produce statistical reports and contribute to the writing of CSR and regulatory submissions.
  • Interact directly with clinical study sites regarding data accuracy and collection.
  • Other related projects as deemed necessary.

Qualifications:

A BSN or Master’s degree in a health or life sciences related field and a minimum 8 years of experience performing clinical endpoint analyses, preferably in therapeutic drug development trials.

Required Skills and Knowledge:

  • Strong working knowledge in clinical trial biostatistical and study endpoint determination analyses
  • Exceptional attention to detail
  • Ability to work effectively in a cross-functional team environment.
  • Strong time-management and organizational skills and the demonstrated ability to manage shifting priorities while maintaining accuracy and quality.
  • Strong analytical and critical thinking abilities.
  • Solid computer skills and proficiency in Microsoft Office and Adobe.
  • Occasional domestic and international travel required (typically less than 25%).
  • Exceptional attention to detail
  • Ability to work effectively in a cross-functional team environment.
  • Strong time-management and organizational skills and the demonstrated ability to manage shifting priorities while maintaining accuracy and quality.
  • Strong analytical and critical thinking abilities.
  • Excellent communication skills.
  • Solid computer skills and proficiency in Microsoft Office and Adobe.
  • Occasional domestic and international travel required (typically less than 25%).