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Statistical Science Director- Early BioPharmaceuticals
3 months ago
Job Description:
- Take a leadership role and drive statistical thinking in cross-functional team projects, within an international environment
- Contribute to strategic planning and quantitative decision making in early clinical development programs
- Lead the delivery and oversight on drug projects and/or studies to time, quality, and standards, including partnering with CROs and with Programming
- Participate in applying, adapting, and/or developing statistical methodology
- Contribute to development of new procedures and standards to increase quality, efficiency, and effectiveness
- Interactions to influence key collaborators and governance
- Acting as a technical expert in interactions with external providers and collaborators
- Mentoring and coaching junior staff and supporting them with education and training in statistics
- Working with regulatory agencies, attending meetings, answering questions
- MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area
- Knowledge of the technical and regulatory requirements related to the role
- Leadership capabilities to be able to lead and direct project work
- Experience of data analysis and interpretation in a relevant area
- Solid understanding of programming in R and/or SAS
- Excellent written and spoken English. Excellent communication skills (including communicating with non-statisticians) and ability to build positive relationships
- Excellent collaboration skills required – the energy to work across global & functional boundaries, both internally and externally
- Ability to apply statistical expertise to sophisticated problems, problem-solving, and quality focus
Desirable in the role, dependent on experience:
- Experience of program and study design
- Experience in the relevant therapeutic area
- Experience of regulatory interactions