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Responsibilities:

• Demonstrated experience with CDASH and CDISC data standards (SDTM, ADaM)
• In-depth knowledge of data standards and demonstrated experience in the handling of data in diverse types. Import data from various sources.
• Program quality control checks for source data and reporting data issues.
• Write programming code following established Good Programming Practices
• Develop SAS Macros as needed.
• Develop high quality graphs in addition to developing Tables, listings, and figures.
• Program/QC SDTM and ADaM datasets and TLFs from external vendors.
• Program to create statistical analysis tables, listing and figures.
• Provides programming support for development or verification of data and analysis, adhoc analysis and. Perform quality check programming activities for CRO deliverables.
• QC CRO deliverables.
• Review and comment on CRF, annotated CRF, edit checks, Statistical Analysis Plan, and other clinical study related documents.
• Review table specifications, analysis data sets, and mapping files for analysis data sets
• Produce or QC SDTM/ADaM datasets and associated define.xml, and tables, figures, and listings (TFLs) for individual studies.
• Create and/or QC TFLs to support publications, internal decision making, board meeting materials, exploratory analysis, or ad-hoc requests with tight timelines.
• Ensures stat programming related documentations in an audit-ready state and review for Trial Master Files
• Ensures compliance with FDA regulations, GCP, ICH guidelines.

Requirements:

• Bachelor's degree or higher in a technical, scientific, or analytic discipline
• Minimum 6+ years of biotechnology or pharmaceutical experience.
• Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language, SQL and SAS/GRAPH
• Experience using SAS version 8 or higher.
• Ability to execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment.
• In-depth knowledge in the analysis of clinical trial data, including integrated analysis of clinical trial data with other data types (biomarker, PK/PD, etc.)
• Solid understanding of industry standards such as CDISC, specifically SDTM, ADaM and controlled terminology and/or ADaM and Pinnacle 21 validation.
• Demonstrated ability to rapidly adapt to changing project and strategic requirements. Takes a fit-for-purpose mindset to daily work as well as long-term vision.
• Produce timely, high quality, and reliable clinical trial data listings, tables, and figures.
• Solid knowledge of pharmaceutical and regulatory requirements, procedures, and policies, including GCP, ICH, 21 CFR part 11, and other related guidance documents.
• Strong verbal and written communication skills.
• Ability to work well in cross-functional teams as a contributor.
• Excellent interpersonal skills and demonstrated ability to establish and maintain professional and productive cross-functional working relationships.