ADAM Standards Engineer

IQVIA; Paris; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

IQVIA is seeking an experienced Statistical Programmer Lead to develop process methodology and coordinate integrated programming solutions for complex studies across multiple teams. You will provide technical leadership, training, and internal consulting to ensure high-quality statistical outputs for clients.

The role emphasizes expertise in ADaM/CDISC standards and SDTM-ADaM datasets, with an expectation to guide projects from planning through validation and delivery.

Qualifikationen

• Master's degree in computer science and/or related field.
• Knowledge of statistics, programming and/or clinical drug development process.
• Advanced knowledge of SAS Base, SAS Graph and SAS Macro Language.
• Strong organizational, interpersonal, leadership and communication skills.
• Ability to manage multiple tasks and projects with accuracy.

Aufgaben

• Perform, plan and coordinate programming for complex studies: programming, testing, and documentation of statistical programs.
• Program and plan integration of databases from multiple studies or sources.
• Develop and coordinate programming documentation including plans and specifications for complex studies.
• Provide advanced technical expertise and lead project solutions to teams and department.

Kenntnisse

Statistics knowledge

SAS Base

Leadership

Project management

Attention to detail

Communication

Ausbildung

Master's Degree in Computer Science

Bachelor's Degree in Computer Science or related field

Tools

P21 for data validation

ADaM metadata programming

CDISC ADaM standards

eSubmission (ADRG/DEFINE)

Jobbeschreibung

Frankfurt, Hesse, Germany

Stockholm, Sweden

Paris, France

Barcelona, Spain

Reading, Berkshire, United Kingdom

Dublin, Ireland

Madrid, Spain

Copenhagen, Denmark

Full time

R1572000

Job Overview

Provide experienced technical expertise to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.

Essential Functions

• Perform, plan and co-ordinate the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing summaries and (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients. May perform and plan the programming of database quality control checks.
• Program and plan the integration of databases from multiple studies or sources.
• Develop and co-ordinate programming documentation including plans and specifications, as appropriate, for complex studies.
• Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to teams and department, for complex studies.
• Perform, plan and co-ordinate the development, implementation and validation of new process technologies, macros and applications.
• Fulfill project responsibilities at the level of statstical team lead for single complex studies or group of studies.
• Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage Out of Scope and resource forecasts for single studies. May manage project budget and resource requirements, and provide revenue forecasts for single studies.
• Provide training and guidance to lower level staff.

Qualifications

• Master's Degree Computer science & Bachelor's Degree Computer science or related field
• Knowledge of statistics, programming and/or 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

Technical skillset:

• 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled