Address
Form of work 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 the project level.
- Generate and/or review 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, and 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/Client.
- 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 the development and review of global standards, templates, processes, SOP's, and Work Instructions.
- Partner with cross-functional groups on timelines, vendor selection and CRO oversight.
Requirements:
- BS or MS in Computer Science & Life Sciences 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 the 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/Client.
- Hybrid work arrangements will allow work from home combined with your presence on-site at our US HQ in Florham Park, NJ.
- Good knowledge of 21CFR11 and GCP.
- Good knowledge of Drug development process and Biostatistics
- Current knowledge in technologies and tools related to Statistical programming or Biostatistics.
