For a confidential consultation call James Carrera on 0044 (0) 207 255 6665 or email your CV to [log in to unmask]
FREELANCE: Senior Biostatistician - Phase II-IV
Based in France
Excellent Rate + Accomodation Provided
12 month rolling contract
Job Summary:
An opportunity has arisen for a Biostatistician to join a multi-disciplinary team to provide biostatistical
oversight for an existing database project within a leading biotech. Contributing to defining research questions, planning & scoping out statistical analyses, conducting those analyses, interpreting and publishing results. To assist in statistical activities related to Clinical and non-clinical studies.
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
* Stay abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field
* Promote and communicate statistical awareness and the role of the Biostatistics department (internal/external; scientific/process)
* Contribute to the continuous improvement of Global Biostatistics
Essential Skills & Capabilities:
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.
They Offer:
Key to all this is a culture based on a deep respect for individual talent, high expectations, a full appreciation of the limitless potential of highly motivated teams and a value system which ensures that every person has every opportunity to make a significant difference.
An excellent opportunity awaits for this renewable contract. Interview times booked and full job specification to review...
If you would to discuss this role in greater detail or your application / suitability to this or further roles, please call me or email me in confidence. If you are not available or suited to this position, please feel free to pass my details on.
We also have a broad variety of other Biometric specific vacancies available in the UK and throughout Europe. Inclusive of SAS programming, Statistical, Clinical programming, Data Management functions, Regulatory Affairs, Clinical Research, QA, Compliance & Validation.
For a confidential consultation call James Carrera on 0044 (0) 207 255 6665 or email your CV to [log in to unmask]
James Carrera Vs. The London Marathon
James Carrera is running the London Marathon on 26th April 2009 to raise money for "The Children's Society" - Registered Charity No. 221124
Please support Children facing danger on a daily basis and James Carrera to raise awareness by logging onto...
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