ADAM Standards Engineer

About the role

Provide experienced technical expertise to develop process methodology for the department to meet internal and external clients’ needs.

Plan and coordinate integrated programming solutions for the full spectrum of statistical programming needs, provide technical leadership and internal consulting including specifications and user needs analysis for complex projects or client requirements.

Responsibilities

• Perform, plan and co-ordinate for complex studies: the programming, testing and documentation of statistical programs for tables, figures and listings; and the programming of analysis databases (derived datasets) and data transfers for internal and external clients.
• May perform and plan programming of database quality control checks.
• Program and plan integration of databases from multiple studies or sources.
• Develop and co-ordinate programming documentation, including plans and specifications for complex studies.
• Provide advanced technical expertise to clients and independently deliver project solutions for complex studies.
• Perform, plan and co-ordinate development, implementation and validation of new process technologies, macros and applications.
• Fulfil project responsibilities at the level of statistical team lead for single complex studies or groups of studies.
• Understand Scope of Work and budget/quote assumptions; estimate completed work, manage Out of Scope and resource forecasts and, where applicable, manage project budget, resource requirements and provide revenue forecasts for single studies.
• Provide training and guidance to lower-level staff.

Requirements

• Education: Master's Degree Computer science & Bachelor's Degree Computer science or related field.
• Knowledge of statistics, programming and/or the clinical drug development process.
• Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro Language.
• Good organizational, interpersonal, leadership and communication skills.
• Ability to effectively manage multiple tasks and projects.
• Excellent accuracy and attention to detail.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Preferred qualifications

• Actively support both the development and ongoing maintenance of standard ADaM metadata programming.
• Strong understanding of CDISC ADaM datasets and experience in managing ADaM standards.
• Hands on experience with P21 for data validation.
• Basic knowledge and understanding of eSubmission docs (ADRG, DEFINE).
• Knowledge on tables, listings and figures is an added advantage.

Skills

Technical skills: Base SAS, SAS Graph, SAS Macro Language; ADaM metadata programming and CDISC ADaM dataset management; P21 for data validation; basic eSubmission docs (ADRG, DEFINE); tables/listings/figures familiarity.

Company context

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence that works to accelerate development and commercialization of medical treatments to improve patient outcomes and population health worldwide.

Relevant source disclaimer

IQVIA maintains a zero tolerance policy for candidate fraud; all information and credentials submitted must be truthful and complete and false statements, misrepresentations or material omissions may result in disqualification or termination in accordance with applicable law.