Manager, C&SP Methodology

Purpose: The Senior Manager, C&SP Methodology is a highly experienced 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, including AI, and methods that increase effectiveness of our partner groups.

The Senior Manager, C&SP Methodology could also provide 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.

You will be responsible 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, including AI, 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.
• Applying a strong customer focus to evaluate stakeholder needs/requirements, thinking broadly end-to-end and deliver relevant solutions, in alignment with departmental technical strategies.
• Leading complex departmental innovation and process improvement projects. May lead or contribute technical clinical and/or statistical programming expertise to cross functional projects.
• Serving 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.
• Maintaining up to date knowledge of industry, functional and departmental processes, trends and technologies ensuring optimal implementation and adoption to support current and future needs.
• Proactively engaging and managing external vendor(s) in building innovative solutions and complex systems as needed.
• Identifying and implementing 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, in collaboration with Statistical Programming Therapeutic Area Heads and Portfolio Leads,
• The design, development, and deployment of innovation projects. Develops roadmaps, 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.
• Collaborating effectively with Clinical & Statistical Programming and partner functions (Data Management, Clinical, Biostats, RMW, IT, Data Sciences and others) and counterparts to achieve project goals to deliver on project needs.
• Leads the identification, evaluation, and responsible adoption of AI and agentic AI opportunities across clinical and statistical programming processes, with a focus on measurable quality, efficiency, and portfolio impact.
• Partners with business, data science, technology, quality, privacy, and regulatory stakeholders to translate needs into scalable AI-enabled solutions, ensuring appropriate governance, validation, human oversight, and risk management.
• Drives AI readiness and adoption by defining use cases, success measures, operating practices, and capability-building approaches, including coaching teams on effective and compliant use of generative AI.

• Bachelor’s degree in computer science, mathematics, data science/analytics, public health or other relevant scientific field with 10 years of programming experience, Master’s degree with 8 years of experience, or a PhD with 6 years of 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.) is required.
• Experts in application development and building automation strategies is required.
• Demonstrated project leadership and management experience is required.
• Demonstrated people management skills and experience in staff performance management and people development. is required.
• Strong problem-solving skills with an emphasis on product development is required.
• 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 is required.
• Experience working on cross-functional teams and leading in a matrix environment is required.
• Demonstrated strong written, verbal communication skills, ability to manage conflicting demands and priorities, and to negotiate successfully is required.
• Knowledge of data structures and relevant languages for data manipulation and reporting (including SAS, R, Python, etc.) is preferred.
• Knowledge of industry standards such as CDISC is preferred.
• Knowledge of a variety of machine learning and advanced statistical techniques is preferred is preferred.
• Experience in the Software Development Life cycle (SDLC) process is preferred.
• Experience with Agile project methodology and/or a High Performing Teams model for project execution is preferred.
• Knowledge of machine learning and advanced statistical techniques is preferred
• Experience working with DevOps tools and supporting cloud-based platforms is preferred
• Demonstrated people management skills and experience in staff performance management and people development is preferred.

Advanced Analytics, Biostatistics, Clinical Data Management, Clinical Trial Protocols, Collaboration, Compliance Management, Data Privacy Standards, Good Clinical Practice (GCP), Proactive Behavior, Program Management, Quality Assurance (QA), Regulatory Affairs Management, Representing, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Tactical Planning, Technical Credibility

The anticipated base pay range for this position is : $140,000.00 - $241,500.00

Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation -120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year

Holiday pay, including Floating Holidays -13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave - 80 hours in a 52-week rolling period10 days

Volunteer Leave - 32 hours per calendar year

Military Spouse Time-Off - 80 hours per calendar year

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.