Principal REMS Program Data Analyst (Work From Home) (Hiring Immediately)
Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: June 2, 2025
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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 .
Keywords: Jazz Pharmaceuticals, Vacaville , Principal REMS Program Data Analyst (Work From Home) (Hiring Immediately), Professions , Palo Alto, California
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