Principal C&SP Methodology Lead

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, focusing on research and innovation in emerging spaces and standard tools development.

Principal Responsibilities

• Provide technical project leadership and expertise supporting the Clinical and Statistical Programming Therapeutic Area / assigned group, research and innovation in emerging spaces and/or standard tools development.
• Collaborate with the user community and departmental/external stakeholders to identify innovation, automation and continuous improvement opportunities.
• Propose, evaluate and develop solutions that drive competitive advantage.
• Oversee and supervise work allocation of internal and external team members as needed.
• Contribute to and may lead departmental innovation and process improvement projects.
• Contribute technical clinical and/or statistical programming expertise to cross functional projects.
• Maintain up to date knowledge of industry, functional and departmental processes, trends and technologies.
• Lead and/or contribute to Therapeutic Area specific innovation/efficiency projects.
• Design and support the implementation of technical solutions for global departmental use, developing implementation plans including documentation and training materials.
• Use technology to improve application performance and recommend strategy.
• Develop and/or oversee the development of technical solutions (e.g. SAS macros, R functions/packages and tools) that support automation of clinical and/or statistical programming activities.
• Collaborate effectively with Clinical & Statistical Programming and partner functions (Data Management, Biostats, RMW, IT, Data Sciences and others).

Functional Manager/People Leader Responsibilities

• Attract and retain top talent, proactively manage performance and actively support talent development and succession planning.
• Ensure organizational effectiveness, transparency, and communication.
• Ensure training compliance and development of appropriate job skills for assigned personnel.
• Oversee work allocation, providing coaching and guidance as necessary.
• Responsible for local administration and decision making associated with the management of assigned personnel.

Education and Experience Requirements

• Bachelor's degree or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field 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.).
• Expert 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, relevant health authority guidelines (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.