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 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 interpretsummariseand 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 qualityefficiencyand 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 QualificationsSkillsand 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 designanalysisand 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 designanalysisand interpretation

Desirable

Collaborationskillsrequired

Ability to apply statisticalexpertiseto problems problemsolvingand quality focus