Principal Statistical Programmer FSP - Standards Team

United States

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The data standard consultant is responsible for statistical programming activities in support of Data Standards stewardship across all compounds/vendors, including collaboration within Data Sciences, Clinical Development, and other functional representatives to develop, maintain and document clinical data standards. This role also acts as a statistical programming subject matter expert (SME) to support outsourced/internal SDTM programming activities, including the data standards technical decision-making to oversee and ensure the quality and timely delivery of SDTM deliverables. He/she will also consult or support development and dependencies across other related Data Standards (i.e., Analysis Dataset models). He/she will support the overall planning, governance and oversight of data standards activities to ensure proper utilization and adherence of data standards.

Key Responsibilities

  • Provides technical and/or operational guidance in the 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
  • Provides data standards governance support in alignment with the vision developed by the Sponsor's Data Standards Council, department Leadership, and industry-based standards policies and procedure
  • Ensures study or program-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and integrity
  • Participates on department data and analytics systems strategy and/or technical development initiatives including systems and technology integration, data sharing, analysis, transfer/access and storage platforms or utilities
  • Participates in clinical data technology-based initiatives

Qualifications

  • Minimum of 5 years’ industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent.
  • Minimum of 3 years data standards experience, specifically SDTM compliance and oversight.
  • Experience supporting Data Standards including data standard governance activities, decision-making and training/communication.
  • Expert understanding of CDISC standards; including but not limited to CDASH, SDTM, ADAM, Controlled Terminology, DEFINE.
  • Experience working with managing data standards using a Meta Data Repository preferred.
  • Excellent written and oral presentation and interpersonal, organizational, analytical, project management and multi-tasking skills.
  • Bachelor’s Degree required in areas of computer science, statistics, mathematics or information sciences, MBA, advanced degree and / or Project Management certification preferred.
  • Clear alignment with the sponsor Core Values:
    • Commitment to People
    • Innovation and Discovery
    • Sense of Urgency
    • Open Culture
    • Passion for Excellence
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* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰

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Tags: CDISC Computer Science Mathematics Pharma SAS Statistics

Region: North America
Country: United States

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