Brief Description:
As a member of the REMS Strategy and Operations department, the Senior Manager, REMS Data Programmer will provide support for FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs and other patient and product risk management initiatives. This role reports to the Associate Director, REMS Analytics and Reporting level of the department in multiple departmental initiatives both in U.S. and global functions. This role will be responsible for leading the programming activities for REMS and Risk Management, developing and reviewing statistical programs, and collaborating with cross-functional teams to ensure the delivery of high-quality REMS Assessment data. Support presentation development and delivery to senior leadership.
Essential Functions/Responsibilities
- Provide support for the development, submission and implementation of U.S. FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs and Risk Management initiatives conducted for product and patient safety.
- Provide advanced technical expertise in data programming languages (e.g., SAS, R, Python) and ensure the development of high-quality, efficient, and well-documented code.
- Collaborate with cross-functional teams to support REMS portal development, implementation, and maintenance, ensuring compliance with REMS requirements.
- Develop and validate analysis datasets, tables, listings, and figures (TFLs) in accordance with CDISC standards.
- Develop interactive dashboards to visualize REMS Assessment data, data quality, and key performance met using Power BI.
- Provide technical guidance and oversight to ensure data programming solutions meet business requirements.
- Collaborate with Business Analysts and/or Solution architect to design and deliver technical solutions align with business requirements and stakeholder needs.
- Ensure audit preparedness and support regulatory inspections for REMS.
- Support daily departmental tasks to meet REMS requirements for multiple products.
Required Knowledge, Skills, and Abilities
- A minimum of 6-8 years of experience in the pharmaceutical industry, including at least 3-5 years in data programming, with a focus on REMS programs or similar regulated environments
- Advanced technical expertise in data programming languages (e.g., SAS, R, Python).
- Proficient in business analysis principles and practices.
- Excellent communication and interpersonal skills, with ability to effectively communicate complex technical concepts to non-technical stakeholders.
- Ability to work in a fast-paced environment and manage multiple priorities
- CDISC Certification desired.
Required/Preferred Education and Licenses
Advanced degree preferred, Bachelor's degree in Computer Science, Statistics, or a related field required.
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