Senior Manager, Biostatistics - Mirum Pharmaceuticals

POSTION SUMMARY

Support Mirum’s publications needs by designing and performing the analysis of clinical trial data. Provide statistical guidance for the publication strategy, define future research questions, plan/execute statistical analyses, provide input and align with the overall publication plan.

Works collaboratively with others in biometrics (e.g., statistical programmers) as well as with other functional groups such as clinicians, medical and scientific affairs colleagues. A successful candidate will utilize both strategic and operational skills, combining innovative statistical thinking with a strong sense of business acumen.

JOB FUNCTIONS/RESPONSIBILITIES

• Work with biometrics and medical affairs leadership to implement and execute departmental and company-wide strategy/goals/objectives.
• Perform and/or oversee statistical analyses using SAS to generate tables, figures, and listings (TFLs) for use in publications/presentations and for internal purposes.
• Ensures quality of deliverables through appropriate testing and active review for completeness and accuracy including oversight of work packages outsourced to CROs to ensure high-quality deliverables within timeline and budget (including developing and implementing an oversight plan).
• Stay up to date with state-of-the-art statistical science by participating in scientific societies, constant review of the clinical and statistical literature, and translate and apply relevant innovative statistical methodology to everyday work.
• Strong communication skills to interpret, explain, and discuss results of complex statistical analyses to both technical and non-technical audiences.
• Educate and disseminate knowledge throughout the organization for areas within the expertise of medical and scientific affairs as well as publications.

QUALIFICATIONS

Education/Experience:

• PhD in related discipline and 3-5 years of related experience; or
• MS/MA degree in related discipline and 6 years of related experience; or
• Equivalent combination of education and experience.

Knowledge, Skills, and Abilities:

• Expertise in statistical methods to support medical and scientific affairs including analysis using the clinical database for scientific meetings, publications, and internal decision-making (generally based on previously conducted randomized clinical trials).
• Identify and implement methods, techniques, procedures, and evaluation criteria to achieve results.
• Strong communication skills to interpret, explain, and discuss results of complex statistical analyses to both technical and non-technical audiences.
• Knowledge of current and novel statistical methods.
• Strong SAS programming knowledge required.
• R programming knowledge is a plus.
• Use broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
• Develop technical and/or business solutions to complex problems.
• Perform a variety of complicated tasks with a wide degree of creativity and latitude.
• Has good general knowledge of other related disciplines.
• Develop strong partnerships within Mirum, its partner organizations, and external experts and become established as a critical member of the team.
• Apply strong analytical and business communication skills.
• Understand how statistical analyses impact the business.

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