Associate Director, Statistical Programming & Analysis

The Associate Director, Statistical Programming & Analysis at Mirum Pharmaceuticals is responsible for managing and overseeing programming activities across various drug development programs. Key responsibilities include providing oversight for statistical programming vendors, developing CDISC-compliant SAS programs, monitoring clinical trial data, and contributing to high-quality reporting processes.

To qualify for the Associate Director, Statistical Programming & Analysis position at Mirum Pharmaceuticals, candidates must have at least a Master’s degree in statistics, biostatistics, or a closely related field. They should also possess a minimum of 7 years of experience in statistical programming within the biotech or pharmaceutical industry, with at least 3 years demonstrating leadership.

In the Associate Director, Statistical Programming & Analysis role at Mirum Pharmaceuticals, you contribute to clinical trial success by ensuring the timely and accurate delivery of statistical programming outputs. This involves overseeing vendors, developing reusable programs for efficient data analysis, and resolving data discrepancies to maintain high quality in clinical research.

Essential skills for the Associate Director, Statistical Programming & Analysis at Mirum Pharmaceuticals include advanced SAS programming, strong analytical abilities, knowledge of FDA and ICH GCP guidelines, and excellent communication skills to engage effectively with cross-functional teams.

The work environment for the Associate Director, Statistical Programming & Analysis at Mirum Pharmaceuticals is fast-paced and dynamic, where agility and adaptability are key. The culture prioritizes collaboration and creativity, making it an exciting and enjoyable place for those who thrive under minimal direction and changing priorities.

When answering this question, highlight specific projects where you successfully utilized SAS programming for clinical trial data analysis and reporting. Be prepared to discuss complexities you faced and how you ensured compliance with regulatory standards.

In your response, outline your approach to vendor management, including setting clear expectations, regular communication, and performance monitoring. Examples of successful vendor collaborations will help illustrate your management style.

Discuss techniques such as implementing validation processes, conducting regular data quality checks, and how you resolve discrepancies. Emphasizing a proactive approach to data integrity will showcase your analytical skills.

Mention resources you follow, such as professional organizations, webinars, or relevant literature. This demonstrates your commitment to continuous learning and up-to-date knowledge in regulatory compliance.

When asked this, choose a project that showcases your leadership capabilities and the challenges you faced. Explain your role, the outcome, and the impact it had on the clinical trial process.

Explain your techniques for prioritization, such as using project management tools, regular team assessments, and strategic scheduling. This shows your capability to handle a busy and dynamic environment.

Discuss the tools you are comfortable with and why you prefer them for data visualization. Mention how these tools enhance the clarity and accessibility of your statistical results for stakeholders.

Provide a specific example demonstrating your problem-solving skills. Talk about the error, how you identified it, the solution you implemented, and what you learned from the experience.

Here, discuss your thoughts on data integrity, compliance, and communication with cross-functional teams. Highlight the importance of a collaborative culture and sharing insights for continuous improvement.

Mention specific strategies you use to facilitate collaboration, such as regular meetings, clear communication channels, and fostering an open environment where team members can share ideas and feedback.