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Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Biostatistics

Job Category:

Scientific/Technology

All Job Posting Locations:

Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Raritan, New Jersey, United States of America, Warsaw, Masovian, Poland

Job Description:

Position Summary: 

The Principal C&SP Methodology Lead is a highly experienced technical programmer/developer with an in-depth understanding of clinical and/or statistical programming processes, tools, systems, and strong project and team leadership skills. This position is responsible for driving technical strategy and implementing departmental innovation solutions within the functional area. 

Operating in 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, exploring, developing and supporting the adoption of innovative technical solutions using cutting edge technologies and methods that increase automation, efficiency and/or quality in the data management, risk based central monitoring, statistical analysis, visualization and regulatory submission of clinical data. 

The Principal C&SP Methodology Lead contributes to and may lead departmental technical innovation initiatives and projects and supports the continuous enhancement of technical capabilities within the department through training and coaching of departmental staff. This position may also provide functional area people leadership to departmental staff in line with business needs. 

 

Principal Responsibilities:  

• Accountable for providing technical project leadership and expertise in roles that directly support Clinical and Statistical Programming Therapeutic Area / assigned group, research and innovation in emerging spaces and/or standard tools development. 

• Collaborates with the user community and departmental/external stakeholders to identify innovation, automation and continuous improvement opportunities. Proposes, evaluates and develops solutions that drive competitive advantage. 

• As needed, oversees and supervises work allocation of internal and external team members. 

• Contributes to and may lead departmental innovation and process improvement projects. As needed, contributes technical clinical and/or statistical programming expertise to cross functional projects. 

• Maintains up to date knowledge of industry, functional and departmental processes, trends and technologies ensuring optimal implementation and adoption to support current and future needs. 

• Leads and/or contributes to Therapeutic Area specific innovation/efficiency projects. 

• Designs and supports the implementation of technical solutions for global departmental use, developing implementation plans including documentation and training materials as appropriate. 

• Responsible for using technology to improve application performance and recommend strategy 

• Develops and/or oversees the development of technical solutions (e.g. SAS macros, R functions/ packages and tools) that support the automation of clinical and/or statistical programming activities across the department, providing technical support and training as needed.   

• Collaborates effectively with Clinical & Statistical Programming and partner functions (Data Management, Biostats, RMW, IT, Data Sciences and others) and counterparts to achieve project goals to deliver on project needs.   

Functional Manager/People Leader Specific: 

• Responsible for attracting and retaining top talent, proactively managing performance and actively supporting talent development and succession planning. Ensures organizational effectiveness, transparency, and communication.  

• Ensures training compliance and development of appropriate job skills for assigned personnel.  Oversees their work allocation, providing coaching and guidance as necessary.  

• Responsible for local administration and decision making associated with the management of assigned personnel. 

Depending on Role Responsibilities could also include: 

• Works closely with Data Transparency group to ensure that all aspects of Data and Patients Privacy are being considered before providing data to requesters 

Principal Relationships:  

• Reports into people manager position within the function.    

• Functional contacts within IDAR include but are not limited to, Departmental Leadership, Clinical and Statistical Programmers, peer groups within department, Regulatory Medical Writing, Data Management, Risk Management Central Monitoring and Clinical Data Standards. 

• Functional contacts within J&J (as collaborator or peer) include but are not limited to Quantitative Sciences, Biostatisticians and IT. 

• External contacts include but are not limited to, external partners, CRO management and vendor liaisons, industry peers and working groups.   

Education and Experience Requirements:  

• Bachelor’s degree or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth) preferred or relevant industry experience. 

• 6-8 years of programming experience with increasing responsibility 

• Experience in software development and testing (e.g., SAS Macros tools, R functions/packages, etc.).  

• Experts in developing applications using various technical stacks not limited to SAS, R and/or Python.   

• Proven ability to translate complex problems into clear and concise programming code/tools.    

• Basic Project management skills and experience.   

• Working 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.   

• Demonstrated strong written, verbal communication skills, ability to manage conflicting demands and priorities and to negotiate successfully.    

• Experience working and leading in a matrix environment.    

 

Preferred Experience:    

• Knowledge of data structures and relevant languages for data manipulation and reporting (including SAS, R, Python, etc.). 

• Knowledge of industry standards such as CDISC, specifically SDTM and controlled terminology and/or ADaM.   

• Experience in Software Development Life cycle (SDLC).   

• Experience developing tools in support of business operations. 

• Experience working with DevOps tools and supporting cloud‐based platforms   

• Demonstrated people management skills and experience in staff performance management and people development.   

 

 

 

Required Skills:

 

 

Preferred Skills:

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, Survey Design