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Principle SSD Stastician

  • Location

    Cambridge, Cambridgeshire

  • Sector:

    Scientific and Pharmaceutical

  • Job type:

    Contract

  • Salary:

    £50.00 - £60.00 per annum

  • Contact:

    Gail Coupe

  • Contact email:

    Gail.Coupe@morson.com

  • Job ref:

    166550GCO_1566218541

  • Published:

    3 months ago

  • Duration:

    12 Months

  • Expiry date:

    2019-08-26

  • Start date:

    23/08/2019

  • Client:

    #

Role and Responsibilities
In this role you will provide statistical expertise for complex design and interpretation of clinical studies, regulatory submissions and commercialisation. You will also act as a coach/guide for less experienced statisticians in the production of analysis, supporting graphics and analysis tables for CSRs, GMA studies or publications.
You will also:
Analyse 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
Provide support to the complex study analysis, regulatory submissions including specification of overview documents and response to regulatory questions
Contribute to the regulatory submissions including specification of overview documents and response to regulatory questions
Identify opportunities for the application of modelling and simulation to improve study design
Identify and apply statistical methodology to improve the process and delivery activities
Perform ad hoc and exploratory data analyses
Contribute to the development of best practice to improve quality, efficiency and effectiveness
Requirements:
MSc or PhD in Statistics, Biostatistics, or Mathematics (containing a substantial statistical component)
Preferred 4+ years experience working within a statistical role for Principal Level. More years experience will be required for a Statistical Science Director level, both however preferably in pharma/healthcare or other relevant area
Knowledge of the technical and regulatory requirements related to the role and able to guide others on these
Experience in drug development, study design, and data analysis and interpretation
Excellent communication skills and ability to build strong relationships
Excellent collaboration skills required - the energy to work across global & functional boundaries, both internally and externally
Project management skills
Ability to apply statistical expertise to complex problems, problem solving and quality focus
Desirable Qualifications:
Experience in Oncology product development
Coaching skills
Experience in commercial or early development support work
Expert statistical programming skills (SAS and R)
Level (Statistical Science Director vs Principal) to be commensurate with experience and abilities