Principal Statistical Programmer FSP - Standards Team

JOB DESCRIPTION

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.

RESPONSIBILITIES

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

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