Responsibilities:
This position supports the centralized management of technology, platforms, inspections, and related process and training for the global Statistical Programming organization. The individual supports the organization to ensure it operates in compliance with departmental and company SOPs, regulatory requirements, and standards.
Primary Activities:
• Business System Ownership (BSO) of platforms or applications and corresponding documents and training
• Partnership in managing, prioritizing, and implementing portfolio projects
• Drive compliance initiatives, change management and communication
• Supports audit and inspections Center of Excellence with audits, inspections and CAPA (Corrective Action and Preventive Action) management
• Engagement with operational staff and partners globally
• Lead and actively contribute to departmental strategic initiative project teams
• Maintenance of SOPs, corresponding processes, assuring they are of high quality
and complaint with regulatory requirements
• Additional responsibilities as delegated by manager
Education and Minimum Requirement:
BA/BS in Computer Science, Statistics, Applied Mathematics, Information Technology, Life Sciences, Engineering, or related field plus 5-8 years in a clinical trial environment (Analysis & Reporting, Information Technology (IT), Data Management etc.) in the pharmaceutical industry, and 3-5 years SAS or R programming experience.
MS in Computer Science, Statistics, Applied Mathematics, Information Technology, Life Sciences, Engineering, or related field plus 2-5 years in a clinical trial environment (Analysis & Reporting, Information Technology, Data Management etc.) in the pharmaceutical industry, and 3-5 years SAS or R programming experience.
Department Required Skills and Experience:
• Effective interpersonal skills and ability to negotiate and collaborate effectively
• Effective written, oral, and presentation skills
• Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
• A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders
Position Specific Required Skills and Experience:
• Comprehensive knowledge of reporting processes (SOPs) that align with regulatory requirements (e.g., 21 CFR Part 11, ICH GCPs) and software development life cycle (SDLC)
• Understanding of Statistical, Clinical, Medical Monitoring and Data Management concepts as applied to drug/vaccine development within the pharmaceutical industry
• Broad knowledge of clinical trials processes, data structures and corresponding tools used to manage, extract, analyze & report data
• Demonstrated success in the assurance of deliverable quality and process compliance
• Ability to anticipate stakeholder requirements; focus on customers; ability to listen to and address stakeholders’ needs and concerns
• Ability and interest to work across cultures and geographies including partnering with statistical programming staff in AP and EU regions and offshore programming resources
• Demonstrated ability to communicate effectively across multiple audiences and clearly explain processes and system functionality to users
• SAS or R programming experience
Preferred skills and Experience
• Experience with SDLC, ALM, SAS, R, Jira, Confluence, Agile, Digital SDLC
• Experience developing and managing a project plan
• Experience as a System Business Analyst (BA)
• Experience developing and maintaining process documents e.g., SOPs
• Experience in process assessment, improvement, and operational excellence
• Active in professional societies
