Senior Manager, Clinical & Statistical Programming (CS&P) Methodology

Johnson & Johnson•Titusville, NJ

2d•Onsite

About The Position

The Senior Manager, Clinical and Statistical Programming (C&SP) Methodology is an experienced technical and team leader who shapes technical and process strategy and delivers solutions that improve quality, efficiency, and innovation. The role supports a Clinical and Statistical Programming Therapeutic Area or assigned group, with a focus on emerging technologies, research and innovation, and the development of standard tools. It identifies stakeholder needs and defines approaches for developing and adopting technical solutions, including AI, that improve the effectiveness of partner groups. Working with departmental leadership, this position helps shape and implement the department’s technical strategic vision and may provide people or matrix leadership. The role leads complex innovation and process-improvement projects, develops roadmaps and change-management plans, and explores emerging tools, platforms, technologies, and methodologies for practical application to portfolio needs. It also partners with functional and external stakeholders and vendors to design, develop, and deploy solutions. The role leads the identification, evaluation, and responsible adoption of AI and agentic AI across clinical and statistical programming. It translates stakeholder needs into scalable solutions while ensuring governance, validation, human oversight, and risk management. It also advances AI readiness and adoption by defining use cases, success measures, operating practices, and capability-building approaches, including coaching teams in effective and compliant generative AI use. The position is based in Raritan or Titusville, New Jersey, or Spring House, Pennsylvania. Candidates must already be authorized to work in the country of employment; immigration sponsorship and relocation support are not available.

Requirements

Bachelor’s degree in computer science, mathematics, data science/analytics, public health, or another relevant scientific field with 10 years of programming experience; a master’s degree with 8 years of experience; or a Ph.D. with 6 years of experience.
Experience in software design, development, and testing, such as developing SAS macros or R functions, packages, and tools.
Expertise in application development and building automation strategies.
Demonstrated project leadership and management experience.
Demonstrated people-management skills, including staff performance management and people development.
Strong problem-solving skills, with an emphasis on product development.
In-depth knowledge of programming practices, tools, and processes; relevant health authority guidelines such as ICH-GCP and 21 CFR Part 11; and clinical R&D concepts.
Experience working on cross-functional teams and leading in a matrix environment.
Strong written and verbal communication skills, ability to manage conflicting demands and priorities, and ability to negotiate successfully.

Nice To Haves

Experience in a pharmaceutical or clinical-trial environment.
Knowledge of data structures and languages used for data manipulation and reporting, including SAS, R, and Python.
Knowledge of industry standards such as CDISC.
Knowledge of machine-learning and advanced statistical techniques.
Experience with the software development life cycle (SDLC).
Experience with Agile project methodology and/or a High Performing Teams model for project execution.
Experience with DevOps tools and support for cloud-based platforms.
Demonstrated people-management skills and experience in staff performance management and people development.

Responsibilities

Provide strategic technical leadership and expertise supporting Clinical and Statistical Programming Therapeutic Areas or assigned groups, including research and innovation in emerging areas such as AI and standard tools development.
Partner with leads, user communities, departmental stakeholders, and external stakeholders to identify innovation, automation, and continuous-improvement opportunities.
Propose, evaluate, and develop solutions and strategies that create competitive advantage.
Assess stakeholder needs with an end-to-end customer focus and deliver relevant solutions aligned with departmental technical strategies.
Lead complex departmental innovation and process-improvement projects.
Provide or contribute clinical and/or statistical programming expertise to cross-functional projects.
Serve as a departmental resource in areas of technical expertise and coach and train programmers to enhance technical capabilities.
Maintain current knowledge of industry, functional, and departmental processes, trends, and technologies.
Engage and manage external vendors in developing innovative solutions and complex systems as needed.
Identify and implement strategic opportunities to develop and adopt tools, technologies, and methods that improve portfolio-delivery efficiency within and across Therapeutic Areas.
Design, develop, and deploy innovation projects; develop roadmaps, implementation strategies, and change-management plans.
Lead projects exploring emerging tools, platforms, technologies, and methodologies for application to portfolio needs.
Collaborate with Clinical and Statistical Programming and partner functions, including Data Management, Clinical, Biostatistics, RMW, IT, and Data Sciences, to deliver project goals.
Lead identification, evaluation, and responsible adoption of AI and agentic AI opportunities, emphasizing measurable quality, efficiency, and portfolio impact.
Partner with business, data science, technology, quality, privacy, and regulatory stakeholders to develop scalable AI-enabled solutions with appropriate governance, validation, human oversight, and risk management.
Drive AI readiness and adoption by defining use cases, success measures, operating practices, and capability-building approaches, and coach teams on effective and compliant generative AI use.

Benefits

Participation in the company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Vacation: 120 hours per calendar year, subject to policy and date of hire.
Sick time: 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents, subject to policy and date of hire.
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 a child’s birth, adoption, or foster-care placement.
Bereavement leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver leave: 80 hours in a 52-week rolling period.
Volunteer leave: 32 hours per calendar year.
Military spouse time off: 80 hours per calendar year.