Job description

RESPONSIBILITIES:

• Creation of SAS programs to Develop or Validate SDTM/ADaM/TLFs.
• Provide oversight for CRO SDTM/ADaM/TLFs deliverables for multiple studies and make sure efficiencies are gained at project level.
• Generate and/or review of SDTM mapping specifications, annotated CRFs, ADaM specifications, Define.XML documents and reviewer’s guides per CDISC and FDA specifications and guidelines using standard tools and templates.
• Interact with Biostatistics and Regulatory to design and prepare regulatory submission-ready packages and support responses to health authority information requests.
• Provide technical leadership, problem solving of moderate to high complexity and within project timelines while providing high quality deliverables.
• Demonstrate expertise in the SAS language, procedures, and options commonly used in clinical trial reporting - including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
• Create all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/ISE.
• Accountable for oversight of Statistical Programming deliverables on project level for inhouse and outsourced projects.
• Manage all aspects of Statistical Programming deliverables for multiple studies/projects.
• Support in development and review of global standards, templates, processes, SOPs and Work Instructions.
• Partner with cross functional groups on timelines, vendor selection and CRO oversight.

REQUIREMENTS:

• BS or MS in Computer Science or Biostatistics.
• Minimum of 6 years of industry experience in Statistical Programming to include oversight of CRO deliverables.
• Expertise in the SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
• Experience in development and validation of CDISC SDTM and ADaM data models by transforming raw data into standard domains and development and validation of Tables/Listings/Figures.
• Extensive experience of data integration.
• Must possess the ability to work in a team environment.
• Excellent written, verbal and interpersonal communication skills.
• Creation of all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/ISE.
• Hybrid work arrangements will allow work from home combined with your presence on-site at our US HQ in Florham Park, NJ.

Job Types: Full-time, Contract

Schedule:

• Day shift
• Monday to Friday

Experience:

• Python: 1 year (Preferred)
• SQL: 1 year (Preferred)

Work Location: Remote

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