Senior C&SP Methodology & Innovation Lead

Johnson & Johnson Innovative Medicine; Beerse; Sur place; EUR 100 000 - 150 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine seeks a Principal C&SP Methodology Lead, a senior technical role driving clinical and statistical programming innovation and automation. You will guide cross-functional teams and shape strategic technical solutions, with emphasis on SAS, R, and Python, to improve data management, analysis, and regulatory submission processes.

The role demands extensive programming experience, leadership in a matrix environment, and strong communication skills to collaborate

Qualifications

• Bachelor’s degree or equivalent in CS/Math/Data science or related field.
• 6-8 years of programming experience with increasing responsibility.
• Experience in SAS Macros tools, R functions/packages, etc.
• Proven ability to translate complex problems into clear programming code/tools.
• Basic Project management skills and experience.
• Working knowledge of guidelines such as ICH‑GCP, 21 CFR Part 11.
• Strong written and verbal communication; ability to manage conflicting demands.
• Experience in a matrix environment.
• Knowledge of CDISC SDTM/ADaM preferred.

Responsabilités

• Provide technical project leadership for Clinical and Statistical Programming teams.
• Lead innovation and automation solutions within the department.
• Oversee work allocation of internal and external staff.
• Design and implement technical solutions (SAS/Macros, R, Python) and provide training.
• Collaborate with Data Management, Biostatistics, IT and partner functions to meet project goals.
• Maintain knowledge of industry trends and technologies for optimal implementation.

Connaissances

Advanced Analytics

Biostatistics

Clinical Data Management

Collaboration

Compliance Management

Critical Thinking

Data Privacy Standards

GCP

Organizing

Presentation Design

Program Management

QA

Regulatory Affairs

Research Docs

SOPs

SAS Programming

Survey Design

Formation

Bachelor’s degree or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field

Outils

SAS

R

Python

Description du poste

Johnson & Johnson Innovative Medicine seeks a Principal C&SP Methodology Lead, a senior technical role driving clinical and statistical programming innovation and automation. You will guide cross-functional teams and shape strategic technical solutions, with emphasis on SAS, R, and Python, to improve data management, analysis, and regulatory submission processes.

The role demands extensive programming experience, leadership in a matrix environment, and strong communication skills to collaborate