ADAM Standards Engineer

IQVIA LLC; Reading; On-site; GBP 55,000 - 75,000; Full time

Job summary

IQVIA in Reading, United Kingdom seeks an experienced Technical Expert in statistical programming to develop process methodology and plan integrated programming solutions for clients and internal teams.

You will lead the programming of complex studies, ensure documentation, and provide advanced technical expertise across ADaM standards and CDISC. A strong background in SAS and data validation is essential.

Qualifications

• Master's degree in computer science or related field.
• Strong knowledge of Base SAS, SAS Graph and SAS Macro Language.
• Experience with CDISC ADaM datasets and managing ADaM standards.
• Experience in statistical programming for complex studies.

Responsibilities

• Develop and coordinate programming for complex studies including statistical tables, figures and listings.
• 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 to clients and teams, independently bringing project solutions.
• Develop, implement and validate new process technologies, macros and applications.
• Fulfill project responsibilities at the level of statistical team lead for single complex studies or group of studies.
• Understand scope, budget and quote assumptions, estimate work, manage Out of Scope and resource forecasts; may manage budget.
• Provide training and guidance to lower level staff.

Skills

Base SAS

SAS Graph

SAS Macro Language

ADaM datasets

CDISC ADaM

Data validation

Leadership

Project management

Statistics

Clinical drug development

Education

Master's Degree Computer science

Bachelor's Degree Computer science or related field

Tools

P21

Job description

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.
  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.