Principal C&SP Methodology Lead
PharmaCROMedTechClinical ResearchRegulatory AffairsQuality Assuranceheormedicalgcpbiostatisticssaspythonclinical data managementmedical writing
Job description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: Scientific/Technology All Job Posting Locations: Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Raritan, New Jersey, United States of America, Warsaw, Masovian, Poland Job Description: Position Summary: The Principal C&SP Methodology Lead is a highly experienced technical programmer/developer with an in-depth understanding of clinical and/or statistical programming processes, tools, systems, and strong project and team leadership skills. This position is responsible for driving technical strategy and implementing departmental innovation solutions within the functional area. Operating in roles that directly support the Clinical and Statistical Programming Therapeutic Area (or assigned group), this position focuses on research and innovation in emerging spaces and standard tools development. This position is responsible for identifying, exploring, developing and supporting the adoption of innovative technical solutions using cutting edge technologies and methods that increase automation, efficiency and/or quality in the data management, risk based central monitoring, statistical analysis, visualization and regulatory submission of clinical data. The Principal C&SP Methodology Lead contributes to and may lead departmental technical innovation initiatives and projects and supports the continuous enhancement of technical capabilities within the department through training and coaching of departmental staff. This position may also provide functional area people leadership to departmental staff in line with business needs. Principal Responsibilities: Accountable for providing technical project leadership and expertise in roles that directly support Clinical and Statistical Programming Therapeutic Area / assigned group, research and innovation in emerging spaces and/or standard tools development. Collaborates with the user community and departmental/external stakeholders to identify innovation, automation and continuous improvement opportunities. Proposes, evaluates and develops solutions that drive competitive advantage. As needed, oversees and supervises work allocation of internal and external team members. Contributes to and may lead departmental innovation and process improvement projects. As needed, contributes technical clinical and/or statistical programming expertise to cross functional projects. Maintains up to date knowledge of industry, functional and departmental processes, trends and technologies ensuring optimal implementation and adoption to support current and future needs. Leads and/or contributes to Therapeutic Area specific innovation/efficiency projects. Designs and supports the implementation of technical solutions for global departmental use, developing implementation plans including documentation and training materials as appropriate. Responsible for using technology to improve application performance and recommend strategy Develops and/or oversees the development of technical solutions (e.g. SAS macros, R functions/ packages and tools) that support the automation of clinical and/or statistical programming activities across the department, providing technical support and training as needed. Collaborates effectively with Clinical & Statistical Programming and partner functions (Data Management, Biostats, RMW, IT, Data Sciences and others) and counterparts to achieve project goals to deliver on project needs. Functional Manager/People Leader Specific: Responsible for attracting and retaining top talent, proactively managing performance and actively supporting talent development and succession planning. Ensures organizational effectiveness, transparency, and communication. Ensures training compliance and development of appropriate job skills for assigned personnel. Oversees their work allocation, providing coaching and guidance as necessary. Responsible for local administration and decision making associated with the management of assigned personnel. Depending on Role Responsibilities could also include: Works closely with Data Transparency group to ensure that all aspects of Data and Patients Privacy are being considered before providing data to requesters Principal Relationships: Reports into people manager position within the function. Functional contacts within IDAR include but are not limited to, Departmental Leadership, Clinica
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