layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Senior Manager, Clinical Data Analytics at Edwards Lifesciences

Experience in clinical safety/pharmacovigilance and regulatory aspects of medical device technology, or equivalent work experience based on Edwards criteria —
Proven successful project management and leadership skills with the ability to influence change
Demonstrated strong problem-solving, process improvement, analytical, and collaborative skills
Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Expert understanding of forecasting, reporting and analytics while addressing issues with impact beyond own team based on knowledge of related disciplines
Expert understanding of related aspects of processes and/or systems
Proficiency in Python (e.g., pandas, NumPy) for clinical/safety data analysis, validation, and QC, with working knowledge of web app frameworks (e.g., Flask, Streamlit, Dash) used to build or extend the safety dashboard application
Experience with a validated clinical/safety database and dashboarding/BI tools (e.g., Tableau, Power BI, Spotfire)
Familiarity with MedDRA/WHO-DD coding conventions and working knowledge of ICH-GCP safety reporting requirements
Working knowledge of cloud-hosted data architectures (AWS preferred) and data lake concepts (ingestion, ETL/ELT, data cataloging) sufficient to partner effectively with engineering teams — not expected to build pipelines personally, but must be able to translate business/safety requirements into technical specs and validate outputs
Proven expertise in MS Office Suite, SharePoint, and ability to operate general office machinery
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment
Ability to frequently interact with customers and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

Senior Manager, Clinical Data Analytics

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