Sr/Principal Biostatistician

Senior Biostatistician

Our Pipeline
Our robust pipeline includes investigational therapies in varied stages of clinical development, from recently approved products to earlier-stage molecules in clinical trials. We aspire to transform the lives of patients around the world.
We have an exciting opportunity available for a Senior Biostatistician in our Gaithersburg Maryland Office or our Cambridge UK location.
Position Summary
Biometrics and Information Sciences (B&I) drives good design to generate data needed for quality decision making. Our goal is to deliver value to the pipeline by excellence in delivery, improving decision making and engaging and shaping the external environment while accessing and implementing innovative solutions.
TA Statistics is the group that oversees and delivers all the statistical and programming contribution to design, decision-making, interpretations and communication internally and externally for the TA portfolio of projects and is engaged in shaping the TA external environment.
Responsibilities

• Provides statistical support for standard design and interpretation of clinical programmes, regulatory submissions and commercialisation
• Under guidance of a more experienced statistician will undertake design and analysis of complex studies.
• Analysing internal and external information to inform design decisions and the development of decision criteria
• Applies modelling and simulation to inform study design, assess robustness of results etc
• Develop a Statistical Analysis plan for study and/or project delivery
• Produce analysis, supporting graphics and analysis tables for standard CSRs, GMA studies or publications
• Able to interpret, summarise and communicate results of standard studies.
• Contribute to the improvement of methodology and provide practical solutions for problems
• Apply statistical methodology to improve the process and delivery activities
• Contributes to the development of best practice to improve quality, efficiency and effectiveness

Job Dimensions
Accountable for the quality of their statistical work
Requirements
MSc/PhD in Statistics or Mathematics (containing a substantial statistical component)
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
Competent Statistical Programmer (SAS and R)
Desirable
Collaboration required
Ability to apply statistical expertise to problems, problem solving and quality focus.