Kurzbeschreibung

Hauptaufgaben und KPIs I

Main Job Tasks & KPIs

Develop, validate, and maintain robust statistical programming code (SAS, R, Python) for data preparation, reporting, and quality checks
Plan and coordinate statistical programming milestones, ensuring stakeholders are aligned on timelines, requirements, and deliverables
Lead in creating and updating macros, templates, and automated scripts to streamline data cleaning, data validation, and routine reporting activities
Collaborate with Data Management to implement Data Validation Plans (DVPs), focusing on consistency and error-free datasets
Support Statisticians by preparing datasets (Extract-Transform-Load step) for statistical analysis, adhering to study protocols and SOPs
Implement lean improvements: identify redundant steps, propose innovative solutions, and introduce modern tools (e.g., version control system, dashboards, project management tools)
Assurs version control for programs and codes
Mentor other programmers and coordinate knowledge-sharing to maintain high-quality standards and uniform coding practices
Monitor and report on KPIs: timely completion of deliverables, adherence to SOPs

The employee performs all tasks in alignment with the requirements of the ISO 9001 quality management standard and actively contributes to maintaining and improving the quality system.
The employee undertakes additional responsibilities and duties as assigned by the line manager to support operational and organizational needs related to the Quality Management System.

Generic Requirements

Manages and coordinates statistical programming activities across multiple projects, ensuring alignment with strategic objectives
Demonstrates strong organizational and time-management skills, following through on tasks and enforcing timelines
Communicates technical topics in concise manner to internal stakeholders
Identifies and addresses critical issues quickly, understanding root causes and implementing viable solutions
Act as the key integrator within Clinical Operations, ensuring seamless collaboration among Data Managers, Project Managers, Statisticians, and cross-functional teams for timely data flow and accurate reporting
Advocates lean methods, eliminates outdated processes, and explores new technologies for automation and efficiency
Guides in the line authority, offering mentorship and constructive feedback to other programmers and vendors
Maintains clear documentation, ensuring compliance with standards, SOPs, and regulatory guidelines

Specific Requirements

Bachelor’s degree in a numerical field (e.g., Mathematics, Computer Science); advanced degrees or equivalent experience are advantageous
3–5 years of hands-on statistical programming experience, preferable with strong SAS skills (Base, Macro, SQL); familiarity with other tools (R, Python, PowerShell) is an asset
Solid grasp of fundamental statistical concepts, with an emphasis on data preparation and report generation
Experience with clinical data workflows, including Electronic Data Capture (EDC) systems and data cleaning
Proven ability to integrate data from multiple sources (e.g., EDC, Excel, vendor platforms) and create reports using various software (SAS, Excel Power Query M-language, R, etc.)
Track record of planning and managing project timelines, prioritizing tasks, and meeting deliverables
Strong interpersonal and communication skills
Dedication to continuous improvement—introducing modern software solutions, automating repetitive tasks, and adopting lean processes