Clinical Scientist, Endpoints and Outcomes
Description

miRagen Therapeutics, Inc. is a clinical stage biopharmaceutical company developing proprietary RNA-targeted therapeutics with a specific focus on microRNAs and their role in diseases where there is a high unmet medical need. Using our expertise in RNA-based therapeutics and systems biology, we have created a diverse pipeline of RNA-targeted product candidates. 


Our growing Boulder-based organization is seeking a Clinical Scientist 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 

testing.

• 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.


Requirements

Qualifications: 


A Master’s degree in statistics or health 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 verbal and written communication skills

• 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%).


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