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
• 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.
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%).