General Electric Senior Director Biostatistics in Chalfont St Giles, United Kingdom
Job Description Summary
Provide leadership and guidance as the lead statistician on a project team. For one or more projects, be accountable for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. Act as key statistical advisor within company.
Roles and Responsibilities
Project - Provide statistical support and scientific leadership for selected projects. Accountable for statistical aspects of clinical studies and submissions of the project. Maintain awareness of industry standards and regulatory requirements and novel methodologies.
Mentor people working on the project. Promote teamwork, quality, and innovation. Ensure project team compliance with SOPs and departmental standards.
Resource Management - Plan and track project activities, timelines, and resource use.
Independently coordinate the statistical activities of Contract Research Organizations (CRO) from review of initial proposal to completion of contracted work.
Collaboration - Ensure productive collaborations with other functions in the aligned project team. Represent statistical group in cross function working groups. Contribute to operation process optimization and provide inputs to statistics standards.
Maintain industry standards and regulatory requirements for statistical analysis and reporting results
Provide advanced consulting and statistical training to scientists.
Ph.D. (MS) in statistics or related discipline with strong pharmaceutical experience, including experience in clinical development
Proven success, through previous submissions or significant interactions, in meeting regulatory guidelines and requirements for drug development
Broad knowledge and superior understanding of advanced statistical concepts and techniques. Innovatively applies technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
Supervisory and budget management experience is a plus
Knowledge of data processing and programming
Demonstrated project management, interpersonal skill
Excellent verbal, writing, and presentation skills
Inclusion and Diversity
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Relocation Assistance Provided: No