Dear Allstat,
CK Clinical is recruiting for a Senior Biostatistician to work for a reputable Pharmaceutical organisation in the EU for an initial 12 months. Rates on offer is competitive and can be discussed on application.
The purpose of the role is to provide statistical input for complex protocol development, write statistical analysis plans and perform statistical analyses for statistically complex clinical trials. With direction, you will also write statistical analysis plans and perform statistical analyses for safety and efficiency summaries for regulatory submissions, provide statistical input for statistically routine protocol development and write statistical analysis plans and perform statistical analyses for statistically routine clinical trials You will also ensure that all functional activities are performed to meet the defined timelines and quality specifications.
Main Role and Responsibilities:
* Provide statistical input for statistically routine protocol/CRF development.
* Provide statistical input for statistically complex protocol/CRF development (e.g. trial design; sample size estimation for the most efficient and practical design; patient randomisation; accurate, logical, clear, concise and thorough evaluation of results section; effective CRF specifications to collect data specified in the protocol).
* Write statistical analysis plans for statistically routine clinical trials.
* Write statistical analysis plans for statistically complex clinical trials as well as for integrated safety and efficacy summaries. Analysis plans include the most appropriate statistical methodology and data presentations.
* Analyse statistically routine and complex clinical trials
* Write accurate, logical, clear, concise, thorough and objective statistical methods sections for statistically routine clinical trial reports.
* Review and co-author statistically routine or complex clinical trial reports ensuring the accuracy of the statistical interpretation
During the course of the contract, you will keep abreast of statistical developments and understand and follow all Global Biostatistics SOP's as well as any other relevant SOPs. You will exhibit routine and complex problem solving skills, communicate routine and complex statistical concepts and results to non-statistical internal and external colleagues in a clear, concise, focused and articulate manner, participate effectively on clinical trial teams and with direction, function as the statistical primary contact with external vendors for studies that are outsourced and ensure the accuracy and timelines of the vendor analysis alerting management to any unforeseen circumstances.
Interested applicants will hold a Ph.D. or MSc in Statistics, Biostatistics (Or related discipline) and will hold proven experience in clinical trials (phase III and IV trials desirable) in the Pharmaceutical/Biotechnology industry.
You will have proven experience in internal as well as outsourced clinical trials, a working SAS knowledge and proficiency in SAS/Stat, knowledge of ICH Statistical and Clinical Report Guidelines.
For a confidential discussion or further information, please contact Priya Mukherjee on +44(0)1438 870028 or email an updated CV to [log in to unmask]
Best wishes,
Priya
Priya Mukherjee BSc (Hons) MRec CertRP
Senior Consultant
CK Clinical Limited
9 High Street
Stevenage Old Town
Hertfordshire
SG1 3BG
DD: +44 (0)1438 870028
Mobile: +44 (0) 7714 288632
Tel: +44 (0)1438 743047
Fax:+44 (0)1438 723800
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