Remote Senior Statistician

Location: Gaithersburg, MD
Date Posted: 07-03-2018
 
Candidate Focus & Challenge –
•             Provides statistical expertise for complex design and interpretation of clinical programmes, regulatory submissions and commercialisation
•             Analyses internal and external information to inform design decisions and the development of decision criteria
•             Develop a Statistical Analysis plan for complex studies and/or project deliveries
•             Acts as a coach/guide for less experienced statisticians in the production of analysis, supporting graphics and analysis tables for CSRs, GMA studies or publications
•             Provides support to the complex study analysis, regulatory submissions including specification of overview documents and response to regulatory questions
•             Able to interpret, summarise and communicate results of complex studies
•             Contribute to the regulatory submissions including specification of overview documents and response to regulatory questions
•             Identifies opportunities for the application of modelling and simulation to improve study design
•             Identifies opportunities to improve the methodology and provide practical solutions for problems
•             Identifies and applies statistical methodology to improve the process and delivery activities
•             Contributes to the development of best practice to improve quality, efficiency and effectiveness
 
Candidate Knowledge, Skills & Experience –
•             MSc/PhD in Statistics or Mathematics(containing a substantial statistical component) preferably with experience in pharma/healthcare or other relevant area
•             Knowledge of the technical and regulatory requirements related to the role and can guide others
•             Experience of Development, programme design and data analysis and interpretation
•             Experience of regulatory, commercial or early development support work
•             Good Communication skills
•             Leadership and team working Skills
•             Project Management Skills
•             Coaching Skills
•             Expert Statistical programming skills (SAS and R)
 
Job Dimensions –
•             Accountable for the quality of their statistical work
•             Reports to Biometrics Team Leader
 
Other –
•             Collaboration required
•             Ability to apply statistical expertise to problems, problem solving and quality focus.•
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