Principal C&SP Methodology Lead

Johnson & Johnson Innovative Medicine•Raritan, NJ

About The Position

The Principal C&SP Methodology Lead is a highly experienced technical programmer/developer with in-depth knowledge of clinical and/or statistical programming processes, tools, and systems, along with strong project and team leadership skills. The role drives technical strategy and implements departmental innovation solutions within the functional area, supporting the Clinical and Statistical Programming Therapeutic Area or an assigned group. The position focuses on research and innovation in emerging areas and standard tool development. It identifies, explores, develops, and supports adoption of technical solutions using emerging technologies and methods to improve automation, efficiency, and quality in data management, risk-based central monitoring, statistical analysis, visualization, and regulatory submission of clinical data. The role contributes to or leads departmental innovation initiatives and supports continuous improvement of the department’s technical capabilities through staff training and coaching. It may also include functional people leadership, depending on business needs. The role provides technical project leadership, develops or oversees solutions such as SAS macros, R functions, packages, and tools, and supports their implementation and adoption for global departmental use. It collaborates with internal and external stakeholders, partner functions, and external organizations to meet project goals. Where the role includes people management, it also involves talent retention and development, performance management, training compliance, work allocation, and local personnel administration.

Requirements

6–8 years of programming experience with increasing responsibility.
Experience in software development and testing, such as SAS macro tools or R functions and packages.
Expertise developing applications using technical stacks that may include SAS, R, and/or Python.
Ability to translate complex problems into clear and concise programming code or tools.
Basic project management skills and experience.
Working knowledge of programming practices, including tools and processes; relevant health authority guidelines such as ICH-GCP and 21 CFR Part 11; and clinical R&D concepts.
Strong written and verbal communication skills, with the ability to manage conflicting demands and priorities and negotiate successfully.
Experience working and leading in a matrix environment.
Bachelor’s degree or equivalent in computer science, mathematics, data science/analytics, public health, or another relevant scientific field, or equivalent theoretical/technical depth; relevant industry experience is also noted.

Nice To Haves

Knowledge of data structures and languages for data manipulation and reporting, including SAS, R, and Python.
Knowledge of industry standards such as CDISC, specifically SDTM and controlled terminology and/or ADaM.
Experience with the Software Development Life Cycle (SDLC).
Experience developing tools in support of business operations.
Experience with DevOps tools and cloud-based platforms.
Demonstrated people-management skills and experience in staff performance management and people development.
Preferred skills listed: Advanced Analytics, Biostatistics, Clinical Data Management, Collaboration, Compliance Management, Critical Thinking, Data Privacy Standards, Good Clinical Practice (GCP), Organizing, Presentation Design, Program Management, Quality Assurance (QA), Regulatory Affairs Management, Research Documents, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, and Survey Design.

Responsibilities

Provide technical project leadership and expertise in support of the Clinical and Statistical Programming Therapeutic Area or assigned group, including research and innovation in emerging areas and standard tool development.
Collaborate with users and departmental or external stakeholders to identify innovation, automation, and continuous-improvement opportunities; propose, evaluate, and develop solutions.
Oversee and supervise work allocation for internal and external team members as needed.
Contribute to or lead departmental innovation and process-improvement projects, and provide technical clinical or statistical programming expertise to cross-functional projects as needed.
Maintain current knowledge of industry, functional, and departmental processes, trends, and technologies to support optimal implementation and adoption.
Lead or contribute to Therapeutic Area-specific innovation and efficiency projects.
Design and support implementation of technical solutions for global departmental use, including implementation plans, documentation, and training materials as appropriate.
Use technology to improve application performance and recommend strategy.
Develop or oversee technical solutions, such as SAS macros, R functions, packages, and tools, to automate clinical and/or statistical programming activities; provide technical support and training as needed.
Collaborate with Clinical and Statistical Programming and partner functions, including Data Management, Biostatistics, RMW, IT, and Data Sciences, to achieve project goals.
When serving as a functional manager or people leader, attract and retain talent, manage performance, support talent development and succession planning, and promote organizational effectiveness, transparency, and communication.
When serving as a functional manager or people leader, ensure training compliance and job-skill development, oversee work allocation, and provide coaching and guidance.
When serving as a functional manager or people leader, make local administrative and management decisions for assigned personnel.
Depending on role responsibilities, work with the Data Transparency group to consider data and patient privacy before providing data to requesters.