Technical Lead, Clinical & Statistical Programming

工作内容

Technical Lead, Clinical & Statistical Programming is a highly experience 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 Technical Lead, Clinical & Statistical Programming 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, standard and 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. • 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. • 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. • 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. • Connects with peer groups within the function to identify, influence and leverage synergies in strategy, processes, standards and innovations across Therapeutic Areas. • 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. • Ensures continued compliance with required company and departmental training, time reporting, and other business/operational processes as required for position. In the role of Statistical Programming Therapeutic Area/Value Stream focused Methodology Lead; • Accountable to assigned Statistical Programming Therapeutic Area Head(s) for delivery of innovation and efficiency projects as defined by the Therapeutic Area goals and strategy. • Identifies opportunities and develops and implements innovative technical solutions and methods that increase the efficiency of portfolio delivery across the Therapeutic Area. • In collaboration with Statistical Programming Therapeutic Area Heads and Portfolio Leads, defines detailed plans supporting the roll out of new tools, technologies and methods for early and full adoption within projects engaging cross functional stakeholders where needed. • Leads and/or contributes to Therapeutic Area specific innovation/efficiency projects. • May be sequestered to provide short term, direct hands on support for clinical project analysis and reporting activities. In the role of Research and Innovation Lead; • Designs and supports the implementation of technical solutions for global departmental use, developing implementation plans including documentation and training materials as appropriate. • Leads and/or supports projects exploring and developing emerging tools, platforms, technologies and methodologies for potential practical application in support of portfolio needs. Curates, formalizes and leads practical use cases for Proof of Concept. • Hands on development of prototypes ranging from low resolution models to fully functional prototype use cases. • Provides technical support regarding a spectrum of applications for departmental use. • Supporting UI/UX design for any new application build. In the role of Analysis Code Standards Lead; • Lead development and successful deployment of analysis data standards programming code in alignment with Data Life-cycle Plan(DLP) strategy and release schedule. (may include nonDLP initiatives)….. • Responsible for robust software development plans including design specifications, and test plans and scripts as required, along with user documentation to enable correct adoption of analysis standard code in clinical trials. • Lead the formal change management request in close collaboration with Clinical Data Standards (CDS.) • Responsible for the pre-configuration of the standard in line with the data lifecycle plan while maintaining the traceability and lineage of the data • Responsible for documenting and manging the correct lineage between master standards and the many pre-configured standards. • Responsible for adopting and conformance metrics to identify potential improvement in the adoption of standards in the studies to maximize the value of standards. • Participate and provide input to user requirement discussion meeting with the CDS team for standards. • Responsible for acquiring and maintaining deep expertise in the various code development systems applied in the clinical trials across various analytical platform including SCE and other enterprise applications (C-MORE, Pinnacle 21 etc) that support CDISC standard (SDTM and ADaM) code development. • Provide guidance and technical support to Analysis Data standards technical specialist in coding design. • Participate in industry initiatives related to the industry best practices in developing standard codes. In the role of Applications & Automation tool development Lead; • Develop and/or lead the development of technical solutions that support the automation of clinical and/or statistical programming activities across the department, providing technical support and training as needed. Lead and implements robust software development plans including user requirement specifications, functional specifications, design specifications, and test plans and scripts as required. • Co-ordinate with EBIS and IT technical experts to ascertain system requirements for RPA solutions. • Lead/understand and consistently apply current application development methodology attributes and processes. • Evaluate third-party software application(s) targeted for possible integration into the overall solution, including strategic application(s), tools and utilities. • In collaboration with Research and Innovation and Analysis Data Standards coding teams, Lead/Develop and build application(s) libraries, global code repositories and automation tools to support global standards for Clinical and/or statistical programming needs. As needed as Functional Area People leader; • 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. Qualifications Bachelor’s 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 (Master’s, PhD or equivalent) preferred. *Includes related industry experience of approximately 20+ years without bachelor’s degree. • 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. If no bachelor’s degree approximately 20+ years relevant industry experience is required. • 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. • Software design experience with other languages (e.g. Java, C++, JavaScript, PERL). • Knowledge of a variety of machine learning and advanced statistical techniques. • Experience in Software Development Life cycle (SDLC) process. • Knowledge of machine learning and advanced statistical techniques • Experience working with DevOps tools and supporting cloud-based platforms • Demonstrated people management skills and experience in staff performance management and people development. Primary Location Belgium-Antwerp-Beerse- Other Locations Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-France Organization Janssen Pharmaceutica N.V. (7555) Job Function R&D Requisition ID 2105962660W