Senior Statistician - Pharma

Job Description:

The Senior Statistician I has sufficient experience working as a statistician in the pharmaceutical industry to be working independently on activities relating to design, delivery and interpretation, preclinical studies, regulatory submissions and/or commercialisation. This individual is able to perform and communicate results of more technical analyses, and able to guide less experienced staff. They have the scope to develop creative statistical ideas and approaches, and to apply them in their work.

Competent individual contributor with excellent cross-functional collaboration.

Typical Accountabilities:

The Senior Statistician I may work directly within a project and/or support statistical methodological advances.

The accountabilities for supporting projects directly are:

- Provide statistical expertise for complex design and interpretation for preclinical or clinical programmes, high level internal governance committees, regulatory submissions and/or commercialisation

- Analyse internal and external information, perform modelling and simulation to inform design decisions and the development of decision criteria

- Develop a Statistical Analysis plan for complex studies and/or project deliveries

- Act as a coach/guide for less experienced statisticians in the production of analysis, supporting graphics and analysis tables for study reports, Global Medical Affairs studies or publications

- Able to analyse, interpret, summarise and communicate results of complex studies

- Contribute to the regulatory submissions including specification of overview documents and response to regulatory questions

- Identify opportunities for the application of modelling and simulation to improve study design

- Identify opportunities to improve the methodology and provide practical solutions for problems

- Identify and apply statistical methodology to improve the process and delivery activities

- Contribute to the development of best practice to improve quality, efficiency and effectiveness

- Accountable for the quality of their statistical work; provide discipline-specific understanding, insight and constructive challenge and take ownership of development needs, seek coaching or training opportunities

- The accountabilities for supporting statistical methodological advances are:

- Under guidance of a more experienced statistician, produces pragmatic solutions, often within a tight time scale where the emphasis is to deliver first, then refine and develop solutions thereafter.

- Draft statistical analysis plans for complex studies

- Provide consultancy within area of expertise to fellow statisticians working within therapeutically aligned statistics groups, as well as medical scientists and other key roles across the business

- Investigate and apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration

- Investigate and improve statistical approaches, establish standards and best practice, develop and implement new methodology interacting with external scientists

- Identify new areas where we can add value, developing collaborative relationships with the external scientific/academic community and maintaining academic links

- Contribute to/or lead the development of a process improvement and/or capability area within the Department

- Develop a strong understanding of the pharma business ways of working

- Communicate research and results internally and externally through participation at conferences and journal publications.

Education, Qualifications, and Experience

Essential

- MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or recognized equivalent to stats MSc

- Competent statistical programmer (SAS and R)

- Knowledge of key technical and regulatory requirements

- Experience of design, analysis and reporting of preclinical or clinical studies in more than one setting

- Communication skills

- Collaboration and team working skills

- Experience and knowledge of statistical methods and applications in study design, analysis and interpretation

Desirable

- Collaboration required

- Ability to apply statistical expertise to problems, problem solving and quality focus