Mirum Pharmaceuticals is looking to hire a Senior Manager/Associate Director, Statistical Programming to manage and oversee programming activities for multiple drug development programs, ensuring quality and timely delivery of analyses and reports for clinical trials, regulatory filings, and internal decision-making.
Requirements
- 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.
- 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.
- 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.
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.
- Monitor and evaluate ongoing clinical trial data and contribute to the resolution of data discrepancies.
- 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.
- 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.
Other
- Master’s degree in statistics, biostatistics, data science, or a closely related field preferred.
- Work collaboratively with multiple stakeholders to manage priorities and resources; understand and perform in accordance with regulatory standards and drug development principles.
- 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.
- Other duties as assigned.
