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Associate Director, Technical Lead

Company: J&J Family of Companies
Location: San Diego
Posted on: May 6, 2021

Job Description:

The Associate Director Technical Lead, Clinical & Statistical Programming is a highly experience technical and team leader with an in-depth understanding of clinical and/or statistical programming processes, tools/systems and strong project and team leadership skills. This position is accountable for influencing, shaping and developing technical and process strategy and solutions that deliver increased quality, efficiency and innovation solutions within the functional area. Operating in project and team leadership 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 and evaluating stakeholder needs, as well as defining and implementing the development and adoption strategy 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 Associate Director Technical Lead, Clinical & Statistical Programming, also provides functional area people and/or matrix leadership to departmental staff. In collaboration with senior departmental leadership, this position influences departmental effectiveness acting as a change agent to shape, drive and implement departmental technical strategic vision. Principal Responsibilities: Accountable for providing strategic technical 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. Strategic partnering with leads, user community and departmental/external stakeholders to identify innovation, automation and continuous improvement opportunities. Proposes, evaluates and develops solutions and strategies that drive competitive advantage. Applies a strong customer focus to evaluate stakeholder needs/requirements, thinking broadly end-to-end and deliver relevant solutions, in alignment with departmental technical strategies. Coordinates work allocation of internal and external team members. Leads complex departmental innovation and process improvement projects. May lead or contribute technical clinical and/or statistical programming expertise to cross functional projects. Leads community of practice identifying, influencing and leveraging synergies in strategy, processes and innovations across the department. Serves as a departmental resource in areas of technical expertise. Coaches and trains clinical and/or statistical programmers to support the continuous enhancement of technical capabilities. 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. As needed, proactively engages and manages external vendor(s) in building innovative solutions and complex systems. Ensures continued compliance with required company and departmental training, time reporting, and other business/operational processes as required for position. 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. Reports into people manager position within the function. Functional contacts within IDAR include but are not limited to, Departmental Leadership, Clinical and Statistical Programmers, peer groups within department, Regulatory Medical Writing, Data management, Risk Management Central Monitoring and Clinical Data Standards. Functional contacts within Janssen (as collaborator or peer) include but are not limited to Quantitative Sciences, Biostatisticians, BRQC, EBIS and IT. External contacts include but are not limited to, external partners, CRO management and vendor liaisons, industry counterparts and working groups. QualificationsBachelors degree or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth) required. Advanced Degree (Masters, PhD or equivalent) preferred. Approximately 10+ years programming experience with increasing responsibility OR Masters (or equivalent) in a relevant field and 8+ yrs relevant experience OR PhD in a relevant field and 6+ yrs relevant experience. Experience in a pharmaceutical/ clinical trial environment preferred. Experience in software design, development and testing (e.g. SAS Macros, R functions/packages tools etc). Experts in application development and building automation strategies. Demonstrated project leadership and management experience. Demonstrated people management skills and experience in staff performance management and people development. Strong problem-solving skills with an emphasis on product development. In-depth knowledge of programming practices (including tools and processes), relevant health authority guidelines, such as (e.g. ICH-GCP, 21 CFR Part 11), and relevant clinical R&D concepts. Experience working on cross-functional teams and leading in a matrix environment. Demonstrated strong written, verbal communication skills, ability to manage conflicting demands and priorities and to negotiate successfully. Preferred Experience: Knowledge of data structures and relevant languages for data manipulation and reporting (including SAS, R, Python, etc.) Knowledge of industry standards such as CDISC, specifically SDTM and controlled terminology and/or ADaM. Primary LocationUnited States-New Jersey-Raritan-920 US Highway 202Other LocationsEurope/Middle East/Africa-Belgium-Antwerp, United States-California-San Diego, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-California-South San FranciscoOrganizationJanssen Research & Development, LLC (6084)Job FunctionR&DRequisition ID210#######W Associated topics: administrative assistant, administrative officer, administrative staff, asso, associate, beverage, front office, operation, records management, support

Keywords: J&J Family of Companies, San Diego , Associate Director, Technical Lead, Executive , San Diego, California

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