Senior Manager, Statistical Programming & Analysis
Location
Foster, CA | United States
Job description
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare liver diseases affecting children and adults. Propelled by our passion for patients and their families, we’re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare liver diseases. 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. Learn more about our work, our culture, and what it’s like to be a part of our team: .
POSTION SUMMARY
Reporting to the Associate Director, Statistical Programming and Analysis, the Senior Manager, Statistical Programming and Analysis will be responsible for the management and oversight of programming activities in support of multiple drug development programs. 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; provide programming guidance as needed.
- Work collaboratively with multiple stakeholders as lead programmer 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.
- 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.
- 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.
- Knowledge of FDA and ICH GCP guidelines, clinical data structures/standards (e.g. CDISC), and electronic submissions to ensure the appropriate conduct and analysis of clinical studies.
- Strong communication skills, stakeholder management abilities, and passion to analyze complex issues to develop relevant and realistic programming solutions.
- Ability to take initiative to work with minimal supervision and efficiently adjust workload based upon changing priorities.
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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.
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