Mirum focuses on finding and developing drugs for difficult to treat liver diseases. Our programs are focused on cholestatic liver diseases in children and adults. Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.
Reporting directly to the Senior Director, Biometrics, the Director, Statistical Programming will be responsible for the organization and long-term strategic leadership of the Statistical Programming unit that supports multiple drug development programs. This position will manage the operational aspects of statistical programming supporting global drug development activities and will lead statistical programming initiatives across multiple therapeutic portfolios, as well as manage the selection and oversight of statistical programming vendor partners. This position requires a comprehensive knowledge of SAS and CDISC standards, regulatory filing experience, and a broad understanding of the pharmaceutical drug development process. The successful candidate will provide leadership and guidance to the biometrics department and will be responsible for supporting end-to-end statistical programming activities, including the development and implementation of data standards based on CDISC.
Responsibilities include, but are not limited to:
- Establish and provide leadership to the statistical programming team at Mirum to set a high performance and collaborative culture.
- Ensure quality processes for statistical programming through SOPs, training, and internal and external inspection activities.
- Build and lead a team of high performing statistical programmers to meet business objectives.
- Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives.
- Recruit, manage and provide oversight of Statistical Programming FTEs, contractors and CROs.
- Oversee the development and implementation of Statistical Programming SOPs and work instructions.
- Develop and maintain CDISC-compliant and submission-ready SAS programs, SDTM, ADaM and summary tables and figures.
- Partner with the many functions of Clinical Development and provide programming support as necessary.
- Review and support the development of SAP, Protocol, CRF design and edit-check specifications.
- Monitor and evaluate ongoing clinical trial data and contribute to the resolution of data discrepancies.
- Develop and maintain standard reporting templates.
- Acquire necessary tools to improve programming efficiency and facilitate review of clinical trial data.
- Ensure programming infrastructure supports integrated summaries (ISE/ISS), CSR, conferences/publications, ad-hoc analyses and regulatory deliverables.
- Oversee Statistical Programming department budget and requirements.
- Ensure proper filing of study documentation, regulatory compliance and inspection readiness.
- Other duties as assigned.
Position Requirements & Experience:
- Masters degree (or higher) in Statistics, Computer Science or other closely related field to programming with at least 10 years of clinical/statistical programming experience within pharmaceutical industry and at least 3 years of demonstrated leadership experience and career progression.
- Experience in development and implementation of statistical programming standards and procedures is required.
- Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
- Experience in regulatory GCP inspections/audits.
- Demonstrated ability to manage staff that leads projects for statistical programming and mentoring junior statistical programming and leading teams supporting NDA and IND filings.
- Adept at outsourcing and managing services provided by statistical programming vendors and contractors.
- Extensive experience interacting with regulatory agencies, both US and ex-US.
- Flexible to changing priorities, detail-oriented, works well under pressure with initiative to take on unfamiliar tasks.
- Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction and to accept responsibility for individual and team performance (accountability & ownership).
- Demonstrated ability to evaluate business impact of decisions, follow through on agreed upon decisions, and remain flexible when needed.
- Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Candidates must be authorized to work in the U.S.
To apply, please send your resume to firstname.lastname@example.org.