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Clinical Data Standards Architect Statistical Programming
Spring House, Pennsylvania; Raritan, New Jersey; Titusville, New Jersey
Requisition ID: 6710180321
Janssen Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Clinical Data Standards Architect Statistical Programming with preferred location being in Spring House, PA however Raritan, NJ and Titusville, NJ are acceptable locations. Less than 10% travel is required for this position.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
The CDSA Statistical Programming will take a leadership role in the definition and maintenance of standard metadata supporting the data flow from data delivery to data analysis and reporting and in the design, development and maintenance of standards SAS code supporting the creation of analysis datasets and standard tables listings and figures (TLF).
• Implementing efficient analysis and metadata standards that cover all trial types and trial designs and for the scientific and operational correctness of the metadata standards in support of the R&D portfolio of drug development programs.
• Takes a leadership role in configuring metadata standards to the specific needs and requirements of a Therapeutic Area, compound our Disease Area, generating the expected efficiencies through optimal adoption and reuse of metadata standards and standard SAS code.
• Develops deep expertise in industry standards related to Study Data Tabulation Model (SDTM), Controlled Terminologies (CT), Analysis Data Models (ADaM), define.xml and Therapeutic Area User Guides (TAUG). Encouraged to become member of industry initiatives related to the development of industry standards.
• Consults with the relevant Subject Matter Experts for scientific correctness, correct traceability to the delivery metadata standards and for compliance with industry regulations of the analysis metadata.
• Oversees the maintenance of the metadata standards at a master level to meet additional scientific or operational requirements supporting the R&D portfolio, while tailoring the metadata standards to the needs of a specific indication, compound or drug development program.
• Implementing efficient standard SAS code for creating analysis data sets and generating displays that cover all trial types and trial designs while guaranteeing the scientific and operational correctness of the SAS code.
• Responsible for setting up SAS programs and macros compliant to Janssen SOP, guidelines and conventions and for the testing and QC of programs and macros. To that end, collaborates with the respective functions such as Statistical Programming and Biostatistics.
• Developing SAS code compliant to available set of conventions and practices achieving code that can be easily shared and maintained. The goal is to develop and maintain code that can run on many study designs and meet many study specific situations based on high reliable study metadata specifying the design and study specific situations.
• Provides the necessary support to the clinical teams to achieve consistent adoption of standards in the studies (internally or outsourced to a CRO). Will use adoption and conformance metrics to identify potential improvements in the adoption of standards in the studies to maximize the value of standards.
• Guarantees formal change management control and versioning of the standards is applied and adhered to and the job holder governs formally all the changes to standards and manages multiple versions in line with adoption needs of the clinical trials and drug development programs.
• Provides the leadership in managing contractor or flex staff (internal and contractor/flex) responsible for the deliverables described above such as the definition and maintenance of the metadata and SAS code.
• Participates in process, system, and tool improvement initiatives across the clinical development standards, Integrated Data Analytics and Reporting (IDAR) and Quantitative Sciences (QS)
• Responsible in acquiring and maintaining deep expertise in the various development standard systems applied in the clinical trials such as SAS, Metadata Repositories and Pinnacle 21.
• A BS/BA degree in Life Sciences, Computer Science or equivalent is required.
• A minimum of 4 years of relevant operational experience in statistical programming is required.
• A minimum of 2 years of relevant operational experience in clinical data standards is required.
• Expertise in SAS is required.
• Experience in CDISC standards (SDTM, ADaM, define.xml, etc.) is required.
• Experience in prioritizing and managing multiple tasks simultaneously is required.
• Outstanding written and verbal communication skills in English
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Pennsylvania-Spring House
North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)