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Hi Allstat,

I hope you are all well.

Please find below the PHARMA CONSULTING GROUP's latest PERMANENT VACANCY to based in UK



Associate Director Biostatistics

Global Pharma

UK

Office based

Permanent

Competitive salary


Responsibilities:



*         To provide statistical expertise to phase III?IV clinical programs for therapeutic areas from concept through to analysis

*         Take full responsibility for statistical aspects of phase IIIb/IV marketing- support studies for assigned therapeutic areas

*         Ensure consistency in the entire program for an assigned therapy area in terms of key variables, definitions, statistical methods, and presentation of results

*         Provide considerations of study objectives, designs, methods of clinical assessments and endpoints, statistical power, and statistical methods for the analysis of clinical data

*         Plan and perform additional exploratory analyses of study data as required to ensure the full utilization of study data and the delivery of data which may help support the key marketing messages

*         Statistical responsibility for interaction with Competent Authorities and Ethics Committees to respond to regulatory based questions concerning the statistical considerations behind a study design

*         Contribute to the detailed planning and efficient execution and reporting of clinical studies

*         Write the statistical sections of the study protocol in collaboration with the study team biostatistician, and review and sign off the final version

*         Review and provide input into critical documents such as CRFs and Data Validation Plans

*         Contribute to the development of detailed statistical analysis plans and output specifications

*         Play key role along with the study team biostatistician in preparation and execution of Data Review Meetings

*         Perform and review/QC statistical analyses for clinical studies in accordance with the protocol, statistical analysis plan, good statistical practice, and available regulatory guidelines

*         Review statistical contributions to the clinical study report, including review of tables, figures, and listings

*         Attend investigator meetings and review publications




Your profile:

*         University MSc/PhD degree in Statistics

*         Advanced knowledge of base SAS & SAS/STAT programming required

*         At least 8 yrs industyr experience in applying statistical methods in biomedical research

*         Advanced knowledge and understanding of current company / industry practices related to the statistical analysis of clinical data

*         Very good understanding of entire drug development process  - ability to see the 'big picture'

*         In-depth familiarity with processes and procedures in data management and SAS programming

*         Accurate with a keen eye for detail

*         Dedication to quality and reliability in all work tasks

*         Ability to perform under pressure

*         Very good technical and analytical abilities

*         Extensive pharmaceutical or CRO industry experience



Laura Christie

European Biometrics Manager

Pharma Consulting Group Ltd

DDI:

020 3627 8319

20 St Dunstan's Hill

Tel:

020 3627 8300

London, EC3R 8HY





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Pharma Consulting Group Ltd incorporates Fforde & CSL

This transmission has been issued by Pharma Consulting Group for the information of the addressee only and should not be reproduced and / or distributed to any other person. Unless otherwise agreed in writing, any CV or Candidate details hereto must be read in conjunction with, and are subject to, Pharma Consulting Group's Standard Terms of Business. Its contents are based on information obtained from sources believed to be reliable but Pharma Consulting Group makes no representation and accepts no responsibility or liability as to its completeness or accuracy.
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