Mirum focuses on finding and developing drugs for difficult to treat liver diseases. Our lead program is focused on two severe liver diseases in children, Alagille Syndrome and progressive familial intrahepatic cholestasis (PFIC). Both conditions can result in severe itching, liver damage and a need for liver transplant. Based on a wealth of data from clinical trials spanning multiple years and involving more than one hundred patients, we believe our approach can address the underlying cause of symptoms and liver damage. Our goal is to give families their lives back.
This position is responsible for providing biostatistical advice and strategic leadership from plan to execution during all phases of the drug development process. The director of biostatistics reports to the Chief Scientific Officer.
- Develops and implements the global statistical analysis plans and data management program strategy.
- Provides statistical guidance in the collaborative protocol development process, e.g., defining objectives, endpoints, and sample size considerations.
- Supports NDA, MMA and other regulatory filing preparations.
- Responsible for statistical data mining and outputs for exploratory analysis in conjunction with clinical counterparts.
- Lead data analytics through collection and analysis of multiple data sources to support decision making and product/process quality improvement.
- Authors, reviews and manages statistical analysis plans.
- Oversees the creation of templates for tables, listings and graphs.
- Plans and executes statistical review of CSRs, clinical publications and other communications.
- Responsible for partnering and managing CRO vendors for data management and biostatistics.
- Interacts with executive level management to report on project or program milestones.
- Contributes to decisions on selection of outsourcing partners and oversees their work and other vendors at the study level.
- Determines budgetary and staffing requirements for internal and external resources.
- Encourages collaborations and builds working relationships within the department and cross-functionally.
- Manages others by providing project leadership and mentoring.
- MS or PhD degree in a statistical science or related field.
- 10 years of combined biostatistical experience in a global pharma or biotech company or other clinical research environment.
- Excellent communication skills and ability to present and interpret results to the scientific and clinical teams.
- Previous experience overseeing a cross-functional statistical analysis team.
- Proven ability to work with state-of-the-art technologies in statistical applications and graphical presentations.
- Ability to apply solid technical knowledge with internal business pragmatism and external sensitivity.
- Thorough understanding of regulatory and compliance requirements for clinical statistics and regulatory filings.
- Experience in supporting regulatory submissions.
- Thinks creatively and develops and executes plans within a fast-paced environment.
- Demonstrates successful track record of delivering projects/programs on schedule and within budget.
- Expert at ensuring scientific quality and timeliness of all documents.
- Seen as a strong and highly skilled leader and manager of employees.
- This is a high growth, fast paced small organization. The ability to be productive and successful in a work environment is critical.
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