Senior Manager, REMS Data Programmer

BioSpace; Palo Alto (CA); On-site; USD 136,000 - 204,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401k retirement savings plan

Flexible paid vacation

Job summary

A global biopharma company is seeking a Senior Manager, REMS Data Programmer to support FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs and initiatives. The role involves leading programming activities and developing statistical programs while collaborating with cross-functional teams. Candidates should have 6-8 years of pharmaceutical industry experience, proficiency in SAS, R, Python, and excellent communication skills. This position in Palo Alto offers a competitive salary ranging from $136,000 to $204,000 along with various benefits.

Qualifications

• 6-8 years of experience in the pharmaceutical industry.
• 3-5 years in data programming, focused on REMS programs.
• Advanced programming language expertise.

Responsibilities

• Support FDA mandated REMS programs and Risk Management initiatives.
• Develop statistical programs and ensure quality code.
• Collaborate with teams for REMS portal and dashboard development.

Skills

SAS

R

Python

Business analysis

Communication skills

Education

Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life Sciences or relevant fields

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

• Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; Master’s Degree preferred.

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.