Senior Statistician II - Biostatistics

Senior Statistician II 

Location: Gaithersburg 

The Senior Statistician II has sufficient experience working as a statistician in the pharmaceutical industry to be working independently on activities relating to design, delivery and interpretation, 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 II will work directly within a project.   The accountabilities for supporting projects directly are: 

• Provide statistical expertise for complex design and interpretation for 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  

 
Education, Qualifications, Skills and Experience 

Essential 

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

. 3+ yrs experience of pharmaceutical development, data analysis and interpretation.

• Competent statistical programmer (SAS and R) 

• Knowledge of key technical and regulatory requirements 

• Experience of design, analysis and reporting of 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 skills required   

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