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, regulatorysubmissionsand/or commercialisation. This individualis able toperform 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 IIwillwork directly within a project. The accountabilities for supporting projects directly are:
Provide statisticalexpertisefor complex design and interpretation for clinical programmes, high level internal governance committees, regulatorysubmissionsand/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 Affairsstudiesor publications
Able to analyse, interpret,summariseand communicate results of complex studies
Contribute to the regulatory submissions including specification of overview documents and response to regulatory questions
Identifyopportunities for the application of modelling and simulation to improve study design
Identifyopportunities to improve themethodologyand provide practical solutions for problems
Identifyand apply statisticalmethodologyto improve the process and delivery activities
Contribute to the development of best practice to improve quality,efficiencyand 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,Skillsand Experience
Essential
MSc/PhD in Statistics, Mathematics (containingasubstantialstatisticalcomponent), or recognised equivalent to stats MSc
. 3+ yrs experience of pharmaceutical development, dataanalysisand interpretation.
Competent statistical programmer (SAS and R)
Knowledge of key technical and regulatory requirements
Experience of design,analysisand 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,analysisand interpretation
Desirable
Collaborationskillsrequired
Ability to apply statisticalexpertiseto problems, problemsolvingand quality focus
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.