Senior Manager, Clinical & Statistical Programming (CS&P) Methodology
Biopharma Asia
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Job summary
Johnson & Johnson seeks a Senior Manager, C&SP Methodology in the data science and clinical programming space. Based in Raritan, NJ; Titusville, NJ; or Spring House, PA, you will lead strategic technical direction across Clinical and Statistical Programming, champion AI-driven tooling, and partner with data sciences, IT, and regulatory teams to deliver innovative solutions for portfolio needs.
The role emphasizes project leadership, governance, and scalability of AI-enabled processes, with a
Qualifications
- Bachelor’s degree in computer science or related field with 10 years of programming experience.
- Experience in SAS Macros, R functions/packages.
- Demonstrated project leadership and people management.
- Knowledge of ICH-GCP, 21 CFR Part 11 and SDLC; Agile methods.
Responsibilities
- Provide strategic technical leadership to Clinical and Statistical Programming groups.
- Identify innovation and automation opportunities with stakeholders.
- Lead complex innovation and process improvement projects.
- Collaborate with cross-functional teams to deliver AI-enabled solutions.
Skills
Education
Tools
Job description
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.
Data Analytics & Computational Sciences
Biostatistics
Scientific/Technology
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for our Senior Manager, Clinical and Statistical Programming (C&SP) Methodology position, to be based in Raritan, NJ; Titusville, NJ; or Spring House, PA.
Candidates must already have authorization to work in the country of employment. Immigration sponsorship and relocation support are not available for this position. Candidates authorized to work pursuant to a short-term status (e.g., F-1) who require future immigration sponsorship are not eligible.
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.
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.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check
#LI-Onsite
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
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
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