Job Details

Job Summary:

Excellent opportunity for Senior Statistician looking towards a progressive career move into an Associate Director position. Sitting with the Medical Affairs team this role is responsible for designing, executing and reporting phase IIIb/IV marketing support studies

Requirements:

BACKGROUND:

Global Pharma – excellent career progression.

 

PRIMARY DUTIES:

• Take full responsibility for statistical aspects of phase IIIb/IV marketing-support studies for assigned therapeutic areas
• Provide considerations of study objectives, designs, methods of clinical assessments and endpoints, statistical power, and statistical methods for the analysis of clinical data
• Statistical responsibility for interaction with Competent Authorities and Ethics Committees to respond to regulatory based questions concerning the statistical considerations behind a study design
• Write the statistical sections of the study protocol in collaboration with the study team biostatistician, and review and sign off the final version
• 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
• Attend investigator meetings and review publications
• Give management a considered opinion on the validity and shortcomings of available data when products are being considered for in-licensing
• Keep up with all relevant developments in statistical and related methodologies, and regulatory guidelines and requirements and signal relevant developments in a timely manner for the company
• Inform and influence brand teams and study teams on the basis of professional knowledge to ensure adherence to regulatory guidance as well as agreed standards & practices
• Collaborate with and support the assigned study team biostatistician during the conduct of studies
• Inform study managers and line management immediately of any tasks falling behind schedule
• Instruct CRO’s (written, verbal, presentation) on requirements and timelines (where applicable

 

QUALIFICATIONS / EXPERIENCE REQUIRED:

• University MSc/PhD degree in Statistics
• Advanced knowledge of base SAS & SAS/STAT programming required
• Advanced knowledge and understanding of current company / industry practices related to the statistical analysis of clinical data
• Extensive pharmaceutical or CRO industry experience required

 

KEYWORDS:

Statistician, Clinical Statistician, Biometrics, Data Sciences, statistical analysis plan, Senior Statistician, London SAS, Lotus notes, Associate Director Biostatistics

 

TO APPLY:

For a confidential discussion please telephone Rebecca Bray at AXESS Limited on 020 8560 2300. To apply, please send your CV to jobs@axess.co.uk quoting reference PW5348

Only candidates with EU work authorisation will be considered.

 

ABOUT AXESS:

AXESS has been operating since 1990
We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development
We match professional candidates to the best permanent, contract and interim roles in the market
Visit us at www.axess.co.uk