ADaM Standards Engineer, FSP

ADaM Standards Engineer FSP

Location: homebased anywhere in the United States or Canada

Position Summary:

IQVIA is hiring to expand a sponsordedicated team working fully within the environment of a prominent Pharma company supporting their longterm standards initiatives. The ADaM Standards Engineer will act as ADaM Standards SME in development of standards management strategy and ongoing development and maintenance of standards across the clients portfolio. This role does not involve actual study work but requires a high degree of selfmotivation/direction and attention to detail as well as exceptional problem solving oral & written communication multitasking and team working skills.Previous experience with implementing CDISC standards that supports strategies and processes for clinical trials is required.

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.
• Provides 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.
• Identifies data inconsistencies with respect to data standards compliance and proposes solutions that support data review/efficiencies including ensuring robust master dataset specifications and correct interpretation of protocol analysis and CDISC compliance requirements.
• Ensures study level ADaM datasets are in compliance with CDISC and regulatory submission requirements reviews study submission data packages to ensure quality and integrity.
• Works 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 CDISCrelated metadata terminology and related standards. Provides governance oversight to ensure consistency in metadata use and development.
• Actively monitors for new regulatory requirements related to data standards and/or data submissions; Communicates and provides impact assessment / consultancy to Data Sciences or specific project teams.

Qualifications:

• Bachelors degree in computer science math statistics biology pharmacology or related.
• 8 years experience as a Statistical Programmer with recent experience working on a Global Standards team or have created Global Standards within a Sponsor or CRO environment
• Expert knowledge of SDTM and ADaM data standards and FDA/PMDA/EMA submission requirements required
• Therapeutic experience in Oncology Virology and/or Inflammation is preferred.

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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

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. potential base pay range for this role when annualized is $88300.00 $273200.00. The actual base pay offered may vary based on a number of factors including jobrelated qualifications such as knowledge skills education and experience; location; and/or schedule (full or parttime). Dependent on the position offered incentive plans bonuses and/or other forms of compensation may be offered in addition to a range of health and welfare and/or other benefits.