Job Description

Clinical Programming: Clinical Programming Lead (SDTM Programming)At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease and the development of best-in-industry data science capabilities is critical to our ambition to be most innovative healthcare company.Within Integrated Data Analytics & Reporting (IDAR) Clinical and Statistical Programming (C&SP) we are looking for individuals with the motivation to contribute to the growth of our Clinical Programming team. The Clinical Programming team within C&SP is responsible for SDTM submission-ready deliverables (SDTM specifications, aCRF, datasets, xpt, define.xml, cSDRG), back-end edit checks, listings, tables, to support data cleaning and review activities.The position is accountable for providing expertise, hands on delivery and oversight of clinical programming activities integrating EDC, eSOURCE, third party vendor data, mapping and transformation into an internal Data Review Model (DRM) and CDISC SDTM submission-ready tabulation packages. Additionally, creates and executes edit check programs and listings as well as CRO oversight for outsourced trials.Responsible for creating efficiencies in the clinical data flow using metadata driven approaches and ensuring the highest level of consistency and quality across trials they support.Additionally, they provide expertise in relevant technical areas and on process improvement, maintenance and innovation initiatives working proactively to connect with teams, peers, and leadership within and cross functions, sharing and implementing lessons-learned and shaping processes and practices.Depending on departmental needs, this position may fulfil the role of a Portfolio Lead.Responsibilities Include:\xc2\xb7 Responsible for planning, coordination, oversight, and execution of team activities as appropriate and provides technical and project specific guidance to team members\xc2\xb7 Create and/or review internal Data Review Model (DRM) and SDTM mapping specifications, aCRF, datasets, define.xml, cSDRG for stakeholder use (data cleaning, medical review, central monitoring, adaptive decision making, etc.)\xc2\xb7 Create back-end edit checks, data cleaning and review listings, tables\xc2\xb7 Independently manages interfaces and escalations with cross-functional project teams.\xc2\xb7 Support and/or lead in developing and implementing process, system, and tool improvement initiatives within compliance with departmental processes and procedures.\xc2\xb7 Develop and maintain working knowledge and expertise in programming languages utilized in clinical programming (SAS, SQL, etc.) and apply continuous learning as part of next generation data strategy (R, Python, Scala, Java, etc.).QualificationsQualifications\xc2\xb7 Bachelors degree in Computer, Data or Life Sciences or equivalent work experience is required; Masters degree preferred\xc2\xb7 6+ years of relevant experience in pharmaceutical industry is desired, experience in other industries in Programming role will also be considered\xc2\xb7 In-depth knowledge of protocol, current clinical drug development processes preferred\xc2\xb7 In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS required.\xc2\xb7 Advanced knowledge of SDTM including Define.xml, CDASH, metadata as well as experience transforming transferred vendor data into SDTM preferred, knowledge of ADaM a plus\xc2\xb7 Strong knowledge of complex finding data types, including but not limited to biomarker, digital data such as ECG, imaging, etc. a plus\xc2\xb7 Experience in planning and coordinating on or more team activities preferred\xc2\xb7 Project management skills and knowledge of team management principles are required\xc2\xb7 Demonstrated written and verbal communication skills\xc2\xb7 Aptitude and motivation to learn new technologies and make appropriate recommendations for consideration is preferred\xc2\xb7 Vendor management oversight experience

Johnson & Johnson