ADaM Standards Engineer, FSP at IQVIA

Durham, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical ResearchIndustries

Requirements

Bachelor’s degree in computer science, math, statistics, biology, pharmacology, or related field
8+ years’ experience as a Statistical Programmer
Recent experience working on a Global Standards team or having created Global Standards within a Sponsor or CRO environment
Expert knowledge of SDTM and ADaM data standards
Familiarity with FDA/PMDA/EMA submission requirements
High degree of self-motivation/direction and attention to detail
Exceptional problem solving, oral & written communication, multi-tasking, and team working skills
Previous experience with implementing CDISC standards that supports strategies and processes for clinical trials

Responsibilities

Develop, update, and maintain ADaM standards
Review SDTM standards for updates and impacts on current ADaM CORE standards
Participate in study-specific ADaM submission package reviews across multiple authorities
Provide technical and/or operational support in the delivery and application of industry clinical data standards within the statistical programming data flow (i.e., SDTM, ADaM, DEFINE) for clinical studies, drug programs, and/or in support of drug application submissions
Identify data inconsistencies with respect to data standards compliance and propose solutions that support data review/efficiencies including ensuring robust master dataset specifications and correct interpretation of protocol, analysis, and CDISC compliance requirements
Ensure study level ADaM datasets are in compliance with CDISC and regulatory submission requirements, review study submission data packages to ensure quality and integrity
Work closely with study leads and Data Management on development of data standards to support data collection requirements; including but not limited to specification of Data transfer agreements (DTAs) in alignment with downstream SDTM and other dataset formats, CRF Standard data collection elements, and external data oversight/strategies to ensure downstream compliance for submission
Support in developing, managing, and maintaining libraries of CDISC-related metadata, terminology, and related standards
Provide governance oversight to ensure consistency in metadata use and development
Actively monitor for new regulatory requirements related to data standards and/or data submissions; Communicate and provide impact assessment / consultancy to Data Sciences or specific project teams

Skills

Key technologies and capabilities for this role

ADaMSDTMCDISCStatistical ProgrammingFDAPMDAEMADEFINE

Questions & Answers

Common questions about this position

Is this position remote or home-based?

The position is home-based anywhere in the United States or Canada.

What is the salary for this ADaM Standards Engineer role?

This information is not specified in the job description.

What are the key requirements for this position?

Candidates need a Bachelor’s degree in computer science, math, statistics, biology, pharmacology, or related field, 8+ years’ experience as a Statistical Programmer, recent experience on a Global Standards team or creating Global Standards, expert knowledge of SDTM and ADaM data standards, and familiarity with FDA/PMDA/EMA submission requirements.

What skills are essential beyond technical expertise?

The role requires a high degree of self-motivation/direction, attention to detail, exceptional problem solving, oral & written communication, multi-tasking, and team working skills.

What experience stands out for a strong candidate?

Previous experience with implementing CDISC standards that supports strategies and processes for clinical trials is required, along with recent experience working on a Global Standards team or creating Global Standards in a Sponsor or CRO environment.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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