Principal Statistician - Ophthalmology

Tasks

• Act as lead biostatistician for protocols randomization and analyses
• Conduct statistical input to study documentation and data specifications
• Develop review and oversee statistical analysis plans SAP
• Lead complex projects including integrated analyses and regulatory submissions
• Lead statistical activities across clinical trial lifecycle
• Maintain inspection ready documentation and quality control records
• Mentor biostatistics professionals and support training programs
• Monitor project milestones timelines and resource needs
• Participate in DSMB and DMC statistical oversight
• Perform independent review and quality control of statistical deliverables
• Represent biostatistics on cross functional project teams
• Support R based statistical programming activities
• Support regulatory agency meetings and responses

Perks/Benefits

• Career development
• Flexible work environment
• Fully remote Europe
• Inclusive collaborative culture
• Peer recognition
• Supportive line management
• Technical and therapeutic area training

Skills/Tech-stack

Analysis Plan | Biostatistics | Clinical Research | Clinical Trial Design | Clinical data | Clinical data management | Clinical trial | Data Management | ICH Guidelines | Integrated Analysis | Quality Control | R | Regulatory Submissions | S&OP | Statistical Analysis | Statistical Analysis Plan | Statistical programming | Trial design