Planet Pharma · 20 hours ago
Senior Manager, REMS Data Programmer
United States
Full-time
Remote
Senior Level
$70/hr - $79/hr
6+ years expPlanet Pharma is seeking a Senior Manager, REMS Data Programmer to support FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs. This role involves leading programming activities for REMS and collaborating with cross-functional teams to ensure high-quality data delivery and compliance with REMS requirements.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
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
Bachelors Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields
Preferred
Masters Degree preferred
CDISC Certification desired
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase