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Spring House, Pennsylvania; Raritan, New Jersey
Requisition ID: 6968180323
Janssen Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Programming Manager to be in Spring House, PA or Raritan, NJ with up to 10% travel is required.
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 Programming Manager plans and provides oversight of programming activities (e.g., development, verification and documentation) in support of clinical trial reporting and submissions or that of a statistical programmer (Clinical Programmer) who applies expertise and problem-solving skills to complete programming activities of high complexity and ambiguity benefitting multiple project teams
This role requires an in-depth knowledge of statistical programming and data structures, departmental processes, and relevant clinical research concepts. This role requires a working knowledge of regulatory guidelines, basic project management, and team leadership.
The Programming Manager makes decisions and recommendations that impact the timeliness and quality of deliverables. He/She will have an impact on the programming team members and is accountable for the programming team deliverables for assigned project.
• Developing detailed programming strategy and plans the programming deliverables for a single project.
• Designs and develops programs in support of complex clinical analysis and reporting activities.
• Performs comprehensive review of, and provides input into, project requirements and/or project documentation.
• In the Programming Lead role, coordinates and oversees programming team activities and provides technical and project specific guidance to programming team members to ensure quality and on-time deliverables in compliance with departmental processes. May lead others in an area of expertise that results in increased efficiency and quality of deliverables across multiple projects.
• In a Clinical Programmer role, applies technical and analytical expertise to develop and implement solutions for use on multiple projects, leading to increased efficiency and quality across programming teams.
• Collaborates effectively within statistical programming and with cross-functional working group team members, including internal and external members.
• Initiate and implement ideas or processes that results in increased departmental efficiency, quality, or cost savings.
• Identify opportunities for consistency across projects and propose a solution.
• Proactively keep abreast of new and changing technologies identifying the relevance of incorporating these updates into the department and share with colleagues.
• Proactively keep abreast of changes in regulatory requirements and industry standards and share knowledge with colleagues.
• Identify development opportunities for others and volunteer to mentor or coach.
• Take a leadership role in the statistical programming support for a submission.
• A minimum of a Bachelor degree in Computer Science, Mathematics or other scientific fields is required
• In-depth knowledge of SAS statistical software with a minimum of 8 years SAS programming experience with increasing responsibility, in a pharmaceutical/clinical trial environment is required
• Extensive knowledge of SAS macro language and SAS Graph is desired
• Demonstrated written and verbal communications skill is required
• Must have experience planning programming activities and leading teams of programmers is required.
• Experience working with external vendors/CROs is desired
• Prior experience with Oncology is preferred.
• Knowledge and experience in SDTM and ADaM is required
• A working knowledge of Statistics, clinical trial, relevant regulatory guidelines, basic project management, and team leadership are required.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
United States-Pennsylvania-Spring House
North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)