Senior Manager, Biostatistics

As a Senior Manager in Biostatistics at Mirum Pharmaceuticals, you'll be responsible for generating clinical protocols, developing statistical analysis plans, and producing tables, figures, and listings. Additionally, you'll perform analyses, interpret study results, and ensure the achievement of statistical deliverables in collaboration with clinical teams and statistical programmers.

Candidates for the Senior Manager, Biostatistics role at Mirum Pharmaceuticals should hold an MS/MA degree with 3-6 years of related experience, or a PhD and 2-3 years of relevant experience. Alternatively, an equivalent combination of education and experience is acceptable, along with strong knowledge of SAS and R programming.

In the Senior Manager, Biostatistics role at Mirum Pharmaceuticals, collaboration is key. You will partner with clinical research, statistical programming, and medical writing teams to ensure high-quality deliverables. Your collaboration will facilitate the successful planning and execution of clinical trials across all phases.

Successful Senior Managers in Biostatistics at Mirum Pharmaceuticals must have a strong command of statistical principles, regulatory guidelines, and industry standards. Excellent analytical skills, effective communication abilities for relaying complex concepts, and experience with SDTM/ADaM specifications are also crucial.

Mirum Pharmaceuticals fosters a positive work environment for Senior Managers in Biostatistics characterized by collaboration, creativity, and a supportive culture. The team values open communication and encourages employees to embody company values such as care, realness, and achieving results while maintaining a fun atmosphere.

In answering this question, provide specific examples of clinical trials you've worked on, describing your role, the statistical methods used, and the outcomes of your analyses. Highlight any unique challenges you faced and how you resolved them to demonstrate your problem-solving abilities.

When answering, mention your experience with SAS and R, including specific projects where you applied these tools. Discuss your familiarity with their functionalities, data manipulation capabilities, and how you’ve used them to analyze clinical trial data.

Explain the methods you use to validate your work, such as peer reviews, double-checks, or using statistical programming guidelines. Mention your approach to collaboration with other departments to maintain the quality of deliverables.

In your response, choose a specific example where you clearly articulated your findings to a non-technical audience. Discuss your strategy for simplifying complex concepts and ensuring your message was understood, underscoring the importance of effective communication in biostatistics.

When addressing this, outline your organizational strategies and tools, such as project management software or prioritization techniques. Emphasize the importance of time management and teamwork in ensuring quality outcomes across concurrent projects.

Discuss your approach to identifying, investigating, and resolving discrepancies in data. Provide an example of a situation where you encountered data inconsistencies and describe how you resolved the issue while maintaining the timeline of the project.

Outline your knowledge of key regulatory guidelines relevant to biostatistics and clinical trials, such as FDA and ICH guidelines. Share any experiences where you've applied these regulations to ensure compliance in your statistical analyses.

Provide a detailed example of a past project, discussing the key components of your statistical analysis plan, the rationale behind your chosen methodologies, and the impact it had on the success of the clinical trial.

Highlight your experiences managing collaborations with clinical research organizations or external partners. Discuss your role in ensuring high-quality deliverables and adherence to timelines and budgets.

Explain your commitment to continuous learning in biostatistics, mentioning any courses, conferences, workshops, or literature you engage with to stay updated on the latest tools and methodologies.