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

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

4d•$140,000 - $241,500•Onsite

About The Position

The Senior Manager, C&SP Methodology is a highly experienced technical and team leader with in-depth knowledge of clinical and/or statistical programming processes, tools, and systems. The role shapes technical and process strategy and delivers solutions that improve quality, efficiency, and innovation within the functional area. It provides project and team leadership in support of a Clinical and Statistical Programming Therapeutic Area or assigned group, with an emphasis on research and innovation in emerging spaces, AI, and standard tool development. The position identifies stakeholder needs and defines strategies for developing and adopting innovative technical solutions and methods. It may provide functional or matrix leadership to departmental staff and, in collaboration with senior departmental leadership, help shape and implement the department’s technical strategic vision. The Senior Manager leads complex innovation and process-improvement work, develops and deploys tools and technologies, and partners across Clinical and Statistical Programming and functions such as Data Management, Clinical, Biostatistics, RMW, IT, and Data Sciences. The role also leads responsible AI adoption across programming processes, translating business needs into scalable solutions with appropriate governance, validation, human oversight, and risk management, while building team readiness and compliant use of generative AI.

Requirements

Bachelor’s degree in computer science, mathematics, data science/analytics, public health, or another relevant scientific field with 10 years of programming experience; master’s degree with 8 years of experience; or PhD with 6 years of experience.
Experience in software design, development, and testing, such as SAS macros or R functions and packages.
Expertise 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, tools, 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 negotiate successfully.
Candidates must already be authorized to work in the country of employment; immigration sponsorship is not available, and candidates requiring future sponsorship after short-term work authorization are not eligible.

Nice To Haves

Experience in a pharmaceutical or clinical-trial environment.
Knowledge of data structures and languages 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 cloud-based platforms.
Demonstrated people-management skills and experience in staff performance management and people development.

Responsibilities

Provide strategic technical leadership and expertise in support of a Clinical and Statistical Programming Therapeutic Area or assigned group, including research and innovation in emerging spaces such as AI and standard tool development.
Partner with leads, user communities, and departmental and external stakeholders to identify innovation, automation, and continuous-improvement opportunities; propose, evaluate, and develop solutions and strategies.
Evaluate stakeholder needs and requirements with an end-to-end customer focus, delivering relevant solutions aligned with departmental technical strategies.
Lead complex departmental innovation and process-improvement projects and contribute clinical or statistical programming expertise to cross-functional projects.
Serve as a departmental technical resource and coach and train clinical and statistical programmers to enhance technical capabilities.
Maintain current knowledge of industry, functional, and departmental processes, trends, and technologies to support effective implementation and adoption.
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 increase portfolio-delivery efficiency across Therapeutic Areas, in collaboration with Statistical Programming Therapeutic Area Heads and Portfolio Leads.
Design, develop, and deploy innovation projects; develop roadmaps, implementation strategies, and change-management plans; and lead projects exploring emerging tools, platforms, technologies, and methodologies for portfolio needs.
Collaborate with Clinical and Statistical Programming and partner functions, including Data Management, Clinical, Biostatistics, RMW, IT, and Data Sciences, to achieve project goals.
Lead the identification, evaluation, and responsible adoption of AI and agentic AI opportunities across clinical and statistical programming processes, emphasizing measurable quality, efficiency, and portfolio impact.
Partner with business, data science, technology, quality, privacy, and regulatory stakeholders to translate needs into 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, including coaching teams on effective and compliant generative AI use.
Provide functional or matrix leadership to departmental staff as needed.

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, with different amounts for employees residing in Colorado or Washington, 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: up to 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.