MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSTION SUMMARY
As the compound 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 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.
JOB FUNCTIONS/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.
- Contribute to the development of statistical processes and standards.
- 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 5-8 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 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.
- 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.
- Understand how statistical analyses impact the business.
The salary range for this position is $200,000 to $206,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
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Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Top Skills
What We Do
Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. Mirum’s approved medication is LIVMARLI® (maralixibat) oral solution which is approved in the U.S. for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older.
Mirum’s late-stage pipeline includes two investigational treatments for debilitating liver diseases affecting children and adults. Maralixibat (LIVMARLI), an oral ileal bile acid transporter (IBAT) inhibitor, is currently being evaluated in clinical trials for pediatric liver diseases and includes the MARCH Phase 3 study for progressive familial intrahepatic cholestasis (PFIC) and the EMBARK Phase 2b study for patients with biliary atresia. In addition, Mirum has an expanded access program open in Canada, Australia, the UK and several countries in Europe for eligible patients with Alagille syndrome.
Mirum has submitted a Marketing Authorization Application to the European Medicines Agency for maralixibat for the treatment of cholestatic liver disease in patients with Alagille syndrome.
Mirum’s second investigational treatment, volixibat, also an oral IBAT inhibitor, is being evaluated in three potentially registrational studies including the OHANA Phase 2b study for pregnant women with intrahepatic cholestasis of pregnancy, VISTAS Phase 2b study for adults with primary sclerosing cholangitis, and the VANTAGE Phase 2b study for primary biliary cholangitis.
