Clinical Programming Lead

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 r esponsible 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 Responsible for planning coordination oversight and execution of team activities as appropriate and provides technical and project specific guidance to team members 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 Create back-end edit checks data cleaning and review listings tables Independently manages interfaces and escalations with cross-functional project teams Support and or lead in developing and implementing process system and tool improvement initiatives within compliance with departmental processes and procedures 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 Qualifications Bachelor s degree in Computer Data or Life Sciences or equivalent work experience is required Master s degree preferred 6 years of relevant experience in pharmaceutical industry is desired experience in other industries in Programming role will also be considered In-depth knowledge of protocol current clinical drug development processes preferred 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 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 Strong knowledge of complex finding data types including but not limited to biomarker digital data such as ECG imaging etc a plus Experience in planning and coordinating on or more team activities preferred Project management skills and knowledge of team management principles are required Demonstrated written and verbal communication skills Aptitude and motivation to learn new technologies and make appropriate recommendations for consideration is preferred Vendor management oversight experience