Associate Director, Regulatory Project Management
2 months ago
The Statistical Science Associate Director has experience working as a statistician in the industry to independently perform and lead work within a project, an indication within a more sophisticated project or be recognised as a methodology expert. This individual is able to lead and direct Biometrics work either in house or partnering with CROs to ensure delivery to quality and time.
Typical Accountabilities- Owning the delivery and oversight on a study /indication, potentially as a Global Project Statistician for a standard drug project
- Contributing to statistical methodological advances
- Lead the statistical thinking and contributions to the delivery of studies, development plans, regulatory strategy, health technology assessment and/or commercial activities
- Direct project work, including statistical staff and/or CRO partners, to ensure delivery to standards, quality and time
- Develop design options and provide high quality decision support to enable the business to make informed decisions about a study or project
- Quantify the benefit, risk, value and uncertainty of the emerging asset/product profile
- Investigate and apply novel statistical approaches, for relevant statistical issues and/or regulatory mentorship and/or value demonstration, including modelling and simulation
- Mentor/coach and support the education and training of statistics staff
The accountabilities for supporting methodological advances include:
- Ability to consult across project teams within area of expertise
- Application of expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory mentorship and/or value demonstration, including modelling and simulation
- Produce pragmatic solutions, often within a tight time scale where the emphasis will be to deliver first, then refine and develop solutions thereafter
- Contribute to/or lead the development of a process improvement and/or capability area within the department
- Establish and improve standards and best practice, apply novel statistical approaches to increase effectiveness and efficiency
- Get along with external scientists and represent AstraZeneca Biometrics externally via publications and presentations on novel statistical approaches and best practice
- Mentor/coach and support the education and training of statistics staff in the technical arena
Essential
- MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or recognised equivalent to stats MSc
- Solid understanding of programming in R and/or SAS
- Knowledge of the technical and regulatory requirements related to the role
- Excellent communication skills and ability to build positive relationships
Technical:
- Usually PhD or a relevant topic
- Experience of independent research
- Delivering innovative statistical solutions in an applied environment
Desirable
- Project Management Skills
- Proficiency in SAS and R/Python languages
- Knowledge of Bayesian statistics from theory to computation is a plus
Technical:
- Track record of research and methodological development in Statistics, supported by scientific publications in first-class statistical journals
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