Senior Manager/Manager, Biostatistics

Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults.  Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

POSITION SUMMARY

As the statistical lead applies technical expertise and experience to provide written and verbal recommendations on statistical issues, design and conduct of clinical trials of all phases. Uses initiative to develop, maintain and share knowledge of the theory and application of current statistical methods appropriate for data analysis and clinical trial design. Works collaboratively with clinicians, data managers, biostatisticians, statistical programmers and medical writers in the planning, conduct and analysis of clinical trials.

JOB FUNCTIONS

  • Works with project team members and manages clinical research organizations (CROs) to generate clinical protocol, authors statistical analysis plan/tables, figures, and listings (TFL) templates, specifications, CRFs, and CRF edit checks.
  • Performs analysis, interprets study results, and collaborates with the clinical team to produce interim reports, final reports, and publications.
  • Ensure achievement of statistical deliverables and milestones in coordination with other functions including clinical research, statistical programming, regulatory, data management, and medical writing.
  • Collaborate with statistical programming to ensure that appropriate programs and documentation are being developed for datasets development and outputs generation.
  • Effectively manages CRO to ensure high-quality deliverables within timeline and budget.
  • Responsible for more than one study with concurrent tasks and timelines.
  • Participates in the validation/QC of key study endpoint analysis and submission deliverables.
  • Applies appropriate regulatory guidelines to the projects.

QUALIFICATIONS

Education/Experience:

  • MS/MA degree in related discipline and 3-6 years of related experience; or,
  • PhD in related discipline and 2-3 years of related experience, or;
  • Equivalent combination of education and experience

Knowledge, Skills, and Abilities:

  • Knowledge of appropriate regulations, industry standards, and guidance documents.
  • Ability to interact effectively with biostatistical, data management, operations, and clinical personnel from CROs and companies collaborating with Mirum.
  • Developed/reviewed SDTM/ADaM specifications.
  • Strong SAS and R programming knowledge preferred.
  • Guides the successful completion of major programs, projects and/or functions.
  • Uses broad expertise or unique knowledge and skills to contribute to the development of company objectives and principles and to achieve goals in creative and effective ways.
  • Develops technical and/or business solutions to complex problems.
  • Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
  • Performs a variety of complicated tasks with a wide degree of creativity and latitude.
  • Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
  • Has good general knowledge of other related disciplines.
  • Applies strong analytical and business communication skills.

To apply, please send your resume to careers@mirumpharma.com.