Senior Statistician

My client is a multi-national pharmaceutical manufacturing. We are recruiting a Senior Statistician to join their team.
The Role
• Lead and coordinate the evaluation of analytical studies including characterization, verification, and validation studies
• Expert in the use of design of experiments (DOE) and the statistical contribution to Total Quality.
• Provide Statistical support for Internal and external GX data analysis on all levels of complexity with particular focus on development of GX based In Vitro Diagnostics Devices (IVDDs).
• Retain an up to date knowledge of statistical methods, scientific literature, and software and continuously improve knowledge.
• Keep up-to-date with Regulatory Guidelines and interpret and implement them effectively.
• Provide statistical guidance and support monitoring and controlling processes
• Act as an in-house consultant in the area of statistical data analysis.
• Actively participate in the identification and development of computational methods and tools that improve quality and efficiency of statistical analysis.
• Ensure that analysis methods and processes/workflows are transferred to other members of the team if necessary and that appropriate training is carried out within a timely manner.
• Prepare and present analyses to customers
• Actively participate in the assessment of technical feasibility of particular IVDD projects.
• Actively participate in the study design process for technical phases of IVDD development projects and for other R&D activities resulting in the generation of GX data.
• Participate in the technical assessment of the outcome of different phases of IVDD development projects and present results of such assessment in a concise and factual manner.
• Support the definition of data requirements for particular data analysis projects.
• Liaise with scientific and commercial collaborators on the subjects of study design and GX data analysis.
• Ensure that all projects for which the post holder is responsible are carried out according to the relevant project organisation and management procedures.
• Deputise for Managers/Supervisors in the day-to-day running of the data analysis projects.
The Person
• MSc or PhD in statistics or a related discipline (or equivalent)
• Previous experience in a statistical analysis role involving technical study design and DOE.
• Previous experience of Statistical Process Control (SPC)
• Experience of evaluation of analytical studies design and analysis including characterization, verification, and validation studies.
• Lead specification setting and specification alterations
• Proficient programming and analysis skills in one or more statistical package (e.g. R, Stata, SAS)
• In depth working knowledge of current strategies, tools and techniques in regression analysis (to include time-to-event data analysis)
• Proven effective communication skills (verbal and written) in relation to technical documentation and interaction with specialists and non-specialists in related field.