ADAM Standards Engineer

IQVIA LLC; Deutschland; Remote; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

IQVIA LLC is seeking an experienced statistical programming specialist to develop processing methodologies and lead programming for complex studies, integrating databases from multiple studies and ensuring tables, figures and listings meet client needs.

You will provide technical leadership, validate new process technologies, mentor staff, and contribute to ADaM metadata programming with CDISC standards, P21 validation, and eSubmission knowledge.

Qualifikationen

• Master's and Bachelor's degrees in computer science or related field.
• Knowledge of statistics, programming and/or clinical drug development process.

Aufgaben

• Program and validate statistical programs for tables, figures, listings.
• Coordinate integration of databases from multiple studies.
• Develop programming documentation and specifications.
• Provide technical leadership and internal consulting to teams.
• Plan and implement new process technologies and macros.
• Lead statistical teams on complex studies and manage budgets.
• Provide training to junior staff.

Kenntnisse

Statistical programming

CDISC ADaM datasets

ADaM standards management

Leadership & team guidance

Communication & interpersonal skills

Project multitasking

Attention to detail

Data validation experience

Tables, listings and figures knowledge

Ausbildung

Master's Degree in Computer Science

Bachelor's Degree in Computer Science or related field

Tools

Base SAS

SAS Graph

SAS Macro Language

P21 data validation

ADaM metadata programming

eSubmission docs (ADRG, DEFINE)

Jobbeschreibung

**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.