Clinical Programming Lead (1 of 2 positions)

Janssen Research & Development LLC, a Johnson & Johnson company, is recruiting for a Clinical Programming Lead. The preferred and primary location for this position is Titusville, NJ, but exceptionally skilled candidates may be considered for other Janssen site locations including; Spring House, PA, Beerse Belgium, Allschwil, Switzerland, and High Wycombe, UK. (Remote work options in the United States and Europe may be considered on a case-by-case basis and if approved by the Company.)
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 (Study Data Tabulation Model) 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, planning, 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.
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. 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. Depending on departmental needs, this position may fulfil the role of a Portfolio Lead.
Responsibilities Include:

• Responsible for planning, coordination, oversight, and execution of one or more Clinical Programming trial activities and provides technical and project specific guidance to team members
• Create and/or validate 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, analysis & reporting, etc.) and health authorities submissions;
• Create back-end edit checks, data cleaning and review listings, tables, as needed.
• Independently manages interfaces and escalations with cross-functional project teams.
• Support and/or lead in developing and implementing process, system, and tool improvement initiatives in 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 other related field is required; Master's degree preferred
• At least 6 years of clinical or statistical programming experience with increasing responsibility in the pharmaceutical/clinical trial environment is required.
• Experience within the Oncology therapeutic area is strongly preferred.
• In-depth knowledge of protocol, current clinical drug development processes and regulatory guidelines is preferred.
• In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting is required. Experience with SAS is required, and experience with Python and/or SQL is a plus.
• Advanced knowledge of SDTM including Define.xml, cSDRG, and compliance-validation is required. Experience with CDASH, metadata as well as experience transforming transferred vendor data into SDTM is preferred.
• 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 Clinical Programming activities on one or more clinical trials is preferred.
• Vendor management oversight experience is a plus.
• Excellent written and verbal communication skills are required.
• Aptitude and motivation to learn new technologies and make appropriate recommendations for consideration is required.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The anticipated base pay range for this position is $104,000 to $166,750. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
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