Principal Statistical Programmer FSP - Standards Team
United States
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
* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰
Tags: CDISC Computer Science Mathematics Pharma SAS Statistics
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