Principal Statistical Programmer - ADaM Standards, Oncology

IQVIA Holdings • North Carolina, NC

70d • $88,300 - $273,200

About The Position

IQVIA is hiring to expand a sponsor-dedicated team, working fully within the environment of a prominent Pharma company, supporting their long-term 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 client's portfolio. This role does not involve actual study work but requires a high degree of self-motivation/direction and attention to detail, as well as 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 as well as, strong Oncology experience required.

Requirements

• Bachelor's 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

Nice To Haves

• Therapeutic experience in Oncology, Virology, and/or Inflammation is preferred.

Responsibilities

• Support activities related to Sponsor specific Clinical Data Standards development and maintenance such as standardizing SDTM and ADaM Specifications and TFLs across therapeutic areas and within specific projects
• Support client specific SDTM and ADaM mapping tools
• Review e-submission packages and provide feedback.
• Leading study-related programming activities for a molecule (writing specification for ADaM, ADaM/TLF programming & validation for both Safety & efficacy), primarily involving legacy data.
• 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 CDISC-related 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.

Benefits

• The potential base pay range for this role, when annualized, is $88,300.00 - $273,200.00.
• 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.

What This Job Offers

• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees