Mirum Pharmaceuticals is seeking a Compound Lead to apply technical expertise and experience to provide recommendations on statistical issues, design, and conduct of clinical trials across all phases, aiming to transform the treatment of rare diseases.
Requirements
- PhD in related discipline and 3-5 years of related experience; or MS/MA degree in related discipline and 5-8 years of related experience; or Equivalent combination of education and experience.
- 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.
- 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).
- Strong communication skills to interpret, explain, and discuss results of complex statistical analyses to both technical and non-technical audiences.
Responsibilities
- Lead biostatistical analysis and reporting, document review and data inclusion for NDA submissions by collaborating with cross-functional partners to meet clinical development project deliverables and timelines.
- Provide statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculate sample size, author statistical analysis plans, provide biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory filings.
- Oversee the deliverables for the DMC reviews and interim/final analyses, and author the Data Monitoring Committee (DMC) charter and other similar documents.
- Perform statistical analysis, interpret study results, and present the results with clinical team to upper management team for decision making.
- Act as a biostatistical lead on study projects, directing and collaborating with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation.
- Advise internal and external partners on choices of statistical analysis strategies, reliability of measurements and identifiability of models, and presentation of statistical results.
- Perform and/or oversee statistical analyses using SAS to generate tables, figures, and listings (TFLs) for use in publications/presentations and for internal purposes.
Other
- Embody values: care, be real, get it done, and have fun, seriously.
- 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 on multiple projects independently.
- Works collaboratively with clinicians, data managers, other biostatisticians, statistical programmers and medical writers in the planning, conduct and analysis of clinical trials.
- Utilize both strategic and operational skills, combining innovative statistical thinking with a strong sense of business acumen.
