Janssen Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Statistical Programming Manager to be located in Raritan NJ (USA).
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.
As a member of the Janssen Integrated Data Analysis and Reporting (IDAR), Statistical Programming and Analysis group, the Statistical Programming Manager plays a key role in planning and providing oversight of statistical programming activities (e.g., development, verification and documentation) in support of clinical trial reporting and submissions. In addition, as an experienced statistical programmer (Clinical Programmer) they apply technical 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 Statistical Programming Manager makes decisions and recommendations that impact the timeliness and quality of deliverables. They will have an impact on the programming team members and are 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 team efficiency and/or quality.
•Identifies and implements opportunities for consistency across projects.
•Proactively keeps abreast of new and changing technologies identifying the relevance of incorporating these updates into the department and share with colleagues.
•Proactively keeps abreast of changes in regulatory requirements and industry standards and share knowledge with colleagues.
•Supports development opportunities for others and may act as a mentor or coach.
•Bachelor’s degree or higher and/or equivalent in computer science, mathematics, data science/analytics, or other relevant scientific field (or equivalent theoretical/technical depth).
Experience and Skills:
•Approximately of 6-8 years programming experience with increasing responsibility, preferably in a pharmaceutical/clinical trial environment.
•In-depth knowledge of statistical programming processes, concepts and data structures
•Advanced knowledge of SAS statistical software
•Experience planning programming activities and leading teams of programmers.
•Demonstrated experience working with cross-functional stakeholders and teams.
•Demonstrated written and verbal communication skills.
•Basic project management skills.
•Knowledge and experience working with CDISC SDTM and ADaM
•A working knowledge of Statistics, clinical trial, relevant regulatory guidelines.
•Experience working in the Immunology Therapeutic Area
•Extensive knowledge of SAS Graph.
•A working knowledge of other tools, such as R and Spotfire.
•Experience working with external vendors/CROs.
•Excellent written and spoken English
•Inter-office travel within country/region (approx. 10%)
•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.
United States-New Jersey-Raritan-
Janssen Research & Development, LLC (6084)