Senior Biostatistician - Phase II-IV

Accountabilities/Responsibilities:
*Draft statistical text for study concept documents and protocols (study design, endpoints, sample size, methods for analysis)
*Draft statistical analysis plans
*Draft templates for tables, listings and graphs
*Draft SDF dataset specifications
*Assist in the review of key study-related documents produced by other functions (e.g. CRFs, Data Management Plans etc)
*Write, test, validate and execute software programs to produce SDF datasets and tables, listings and graphs (mostly statistical analysis outputs, some descriptive outputs) for inclusion within CSRs, ISS / ISE, publications and other communications
*Assist in the production of flash reports
*Draft statistical text for Clinical Study Reports, clinical publications and other communications
*Contribute to statistical review and QC of Clinical Study Reports, clinical publications and other communications
*Interface with outsourcing partners and vendors
*Assist in the review of Policies, SOPs and other controlled documents
*Assist with study and systems audits by CQA and external bodies
*Provide input to and participate in intra-departmental and global Biostatistics meetings

Preferably you hold a postgraduate degree in Statistics or Medical Statistics and have experience of using statistical science in an academic environment or in the pharmaceutical, biotechnology or CRO sectors.

Experience of logistic regression modelling, marginal structural modelling and/or Cox regression modelling would be advantageous, as would experience of working in an international environment. Enthusiastic and committed, you will have excellent interpersonal, organisational and communication skills.