Senior 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 the 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, and 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, this role creates and executes edit check programs and listings as well as CRO oversight for outsourced trials. Responsibilities include 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, the role provides expertise in relevant technical areas and on process improvement, maintenance, and innovation initiatives, working proactively to connect with teams, peers, and leadership within and across functions, sharing and implementing lessons-learned, and shaping processes and practices. Depending on departmental needs, this position may fulfill 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 manage 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.
8+ years of relevant experience in the pharmaceutical industry is desired; experience in other industries in a Programming role will also be considered.
In-depth knowledge of protocol and current clinical drug development processes preferred.
In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting, including SAS, R, Python, etc.
Advanced knowledge of SDTM including Define.xml, CDASH, metadata as well as experience transforming transferred vendor data into SDTM preferred; knowledge of ADaM is a plus.
Strong knowledge of complex finding data types, including but not limited to biomarker, digital data such as ECG, imaging, etc. is a plus.
Experience in planning and coordinating one 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.
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