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.
• 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.
In the role of Statistical Programming Therapeutic Area/Value Team focused Methodology Leader; • Accountable to the assigned Statistical Programming Therapeutic Area Head(s) for delivery of innovation projects and efficiencies as defined by the Therapeutic Area goals and strategy. • In collaboration with Statistical Programming Therapeutic Area Heads and Portfolio Leads, identifies and implements strategic opportunities for the development and adoption of innovative new tools, technologies and methods that increase the efficiency of portfolio delivery within and across Therapeutic Areas. • Leads Therapeutic Area specific innovation/efficiency projects
In the role of Research and Innovation Leader; • Accountable for the design, development, deployment of innovation projects. Develops roadmaps and, strategic implementation and change management plans. Leads projects exploring and developing emerging tools, platforms, technologies and methodologies for potential practical application in support of portfolio needs. • Bring new ideas & technology to the table, leads business case development & may own the execution. • Expertise in prototyping. Partner with cross functional teams to assess strategy in creating potential value to the business resulting from idea generation. • Accountable for developing support roadmaps for all production applications. May act as business owner for technical systems. • Develop application support strategy and infrastructure needs. • Develop automation testing strategy to support over all testing process in new and existing applications. • Provide application design recommendations that align with long and short-term clinical and/or statistical programming technical strategies. • Connects and partners across technical groups within J&J to leverage institutional knowledge and solutions.
In the role of Analysis Code Standards Leader; • Accountable for the design, development and successful deployment of analysis data standards programming code in alignment with Data Life-cycle Plan(DLP) strategy and release schedule. • Accountable for developing support roadmaps, appropriate testing and quality review of programming code and user documentation to enable correct adoption of analysis standard code in clinical trials. • Accountable for continuous improvement of analysis standard code to ensure optimization of standards implementation to best meet the needs of the TAs and user community. • Effectively collaborates with key stakeholders, TAs and Clinical Data Standards (CDS) team, to define strategy and implementation plan for DLP development and maintenance. • Responsible for design and development of analysis standard code change management process and ensures the necessary tools are in place for implementation. • 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. • Participates in industry initiatives related to the industry best practices in developing standard codes
In the role of Applications development & Automation strategy Leader; • Oversees 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. • Accountable for the development and implementation of robust software development plans including user requirement specifications, functional specifications, design specifications, and test plans and scripts as required. • Shares experience and knowledge to assist in the building strategy and solutions that are aligned with industry best practices on RPA. • Identify opportunities and support the development of business cases to drive the continued adoption of automation solutions throughout the organization • Accountable for defining automation strategy to build tools and code repository for Global standards
Principal Relationships: • 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.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.
• 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