Senior Manager, REMS Data Programmer (Remote)

Davita Inc.; Palo Alto (CA); Remote; USD 136,000 - 204,000; Full time

Job summary

An opportunity has arisen for a Senior Manager in REMS Data Programming at a leading biopharma company. This position involves overseeing FDA mandated Risk Evaluation and Mitigation Strategies and requires extensive experience in data programming languages like SAS, R, and Python. The successful candidate will collaborate cross-functionally to ensure quality, compliance, and timely delivery of REMS data to senior leadership.

Benefits

Discretionary annual cash bonus

Equity grants

Comprehensive medical, dental, and vision insurance

401k retirement savings plan

Flexible paid vacation

Qualifications

• 6-8 years of experience in the pharmaceutical industry.
• 3-5 years in data programming focused on REMS programs.
• CDISC Certification desired.

Responsibilities

• Lead programming activities for REMS and Risk Management initiatives.
• Develop and validate datasets, tables, listings, and figures in accordance with CDISC standards.
• Collaborate with cross-functional teams throughout the REMS process.

Skills

Data Programming

Communication

Interpersonal Skills

Business Analysis

Fast-paced Environment Adaptability

Education

Bachelor's degree in Computer Science, Statistics, or related field

Advanced degree preferred

Tools

SAS

R

Python

Power BI

Job description

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to
transform the lives of patients and their families. We are dedicated to developing
life-changing medicines for people with serious diseases - often with limited or no
therapeutic options. We have a diverse portfolio of marketed medicines, including leading
therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
Our patient-focused and science-driven approach powers pioneering research and development
advancements across our robust pipeline of innovative therapeutics in oncology and
neuroscience. Jazz is headquartered in Dublin, Ireland with research and development
laboratories, manufacturing facilities and employees in multiple countries committed to
serving patients worldwide. Please visit
www.jazzpharmaceuticals.com
for more information.

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.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $136,000.00 - $204,000.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.