Senior Manager, REMS Data Programmer (Remote)

Jazz Pharmaceuticals; Palo Alto (CA); Remote; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Senior Manager, REMS Data Programmer to lead programming activities for FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs. In this pivotal role, you will collaborate with cross-functional teams to ensure high-quality REMS Assessment data and support the development of interactive dashboards using Power BI. Your expertise in data programming languages such as SAS, R, and Python will be crucial in delivering technical solutions that meet regulatory requirements. Join a dynamic team where your contributions will significantly impact patient safety and product management initiatives.

Qualifications

• 6-8 years in the pharmaceutical industry with focus on data programming.
• Advanced technical expertise in SAS, R, and Python.

Responsibilities

• Lead programming activities for REMS and Risk Management initiatives.
• Develop and validate analysis datasets and TFLs in accordance with CDISC standards.

Skills

SAS

R

Python

Business Analysis

Communication Skills

Education

Bachelor's degree in Computer Science

Bachelor's degree in Statistics

Advanced degree (preferred)

Tools

Power BI

Job description

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.