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.
POSITION SUMMARY
Reporting directly to the Director, Statistical Programming & Analysis, the Senior Manager, Statistical Programming & Analysis will be responsible for the management and oversight of programming activities in support of the brelovitug program. The role will be responsible for providing operational oversight of statistical programming vendors as well as performing in-house programming activities in support of clinical trial analysis and reporting, regulatory filings, and internal decision-making processes.
JOB FUNCTIONS/RESPONSIBILITIES
- Provide programming expertise in support of statistical analysis across multiple clinical trials for inclusion in clinical study reports, regulatory submissions, periodic reporting, and publications.
- Perform oversight of statistical programming vendors to ensure quality and on-time delivery of programming packages.
- Develop and maintain CDISC-compliant and submission-ready SAS programs, SDTM, ADaM and summary tables and figures.
- Work collaboratively with multiple stakeholders to manage priorities and resources; understand and perform in accordance with regulatory standards and drug development principles.
- Monitor and evaluate ongoing clinical trial data and contribute to the resolution of data discrepancies.
- Contribute to overall Biometrics group in developing innovative processes to ensure high data quality and efficient reporting of analysis results.
- Ensure proper filing of study documentation consistent with regulatory compliance and conducive to inspection readiness.
- Take on initiative to stay current on relevant technologies, industry standards and guidelines to improve programming efficiency and facilitate review of clinical trial data.
- Other duties as assigned.
QUALIFICATIONS
Education/Experience:
- Master’s degree in statistics, biostatistics, data science, or a closely related field preferred.
- 5+ years of experience as a statistical programmer within the biotech/pharmaceutical industry with at least 2 years of demonstrated study lead programming experience and career progression.
- Experience in effectively managing statistical programming vendors and/or internal statistical programming resources for the purposes of clinical trial reporting, regulatory filings, and key internal deliverables.
- Experience in regulatory GCP inspections/audits is a plus.
Knowledge, Skills and Abilities:
- Advanced SAS programming skills in performing clinical trial data analysis and reporting.
- Strong analytical skills and demonstrated experience in gathering, interpreting, and analyzing data in clinical research and drug development.
- Working knowledge of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
- Strong communication skills, ability to development rapport among cross-functional stakeholders, and passion to analyze complex issues to develop relevant and realistic programming solutions.
- Ability to at times take initiative to work with minimal supervision and efficiently adjust workload based upon changing priorities.
The salary range for this position is $190,000 to $210,000 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.
#LI-HYBRID
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.
