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AX-7225 Associate Director Biostatistics

AXESS Ltd Published: 12th April 2019
Location
Greater London/Surrey, United Kingdom
Job Type

Description

Ref: AX-7225

 

JOB SUMMARY

Utilising your strategic and statistical expertise as part of the medical affairs group for a leading global pharma company, you will work across a wide variety of phase IIIb/IV clinical programs from concept through to analysis.

 

BACKGROUND

Global organisation – top 20 pharma

Excellent career development opportunities

Fantastic, modern offices

Opportunity to work with key internal and external stakeholders on a local and global level

 

PRIMARY DUTIES

You’ll be working with another UK based statistician and a team of Late Phase study managers and therapy area medics on global late phase studies.

Applying robust statistical methods to the design of new studies ensuring a thorough analysis of study results and where appropriate coordinating additional analyses.

This role will help ensure that the phase IIIB/IV studies conducted have the maximum chance of success, are scientifically robust and meet the strategic objectives which have been defined, dedicated statistical input is required

Ensure consistency in the entire program for an assigned therapy area in terms of key variables, definitions, statistical methods, and presentation of results as well as managing external vendors

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 utilisation 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

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

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

 

QUALIFICATIONS / EXPERIENCE REQUIRED:

Degree educated in quantitative or scientific subjects
Solid experience in applying statistical methods in biomedical research
Advanced knowledge of base SAS & SAS/STAT programming required
In-depth familiarity with processes and procedures in data management and SAS programming
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 knowledge of clinical trials research and drug development programming experience
Experience in working effectively with cross-cultural partners
Solid experience in applying statistical methods in biomedical research
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.

 

BENEFITS:

Comprehensive

 

TO APPLY:

For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300 quoting reference 7225.

To apply, please click the APPLY ONLINE button.

 

KEYWORDS:

SAS, Statistical Programmer, Statistical Programming, Tables, Listings, Figures, TFL, Macros, pharmaceutical, biotech, clinical research, line management, on-boarding, training, project management, vendor management, west London, home based flexibility, SAS, SAS & SAS/STAT, SAS programming, data management, biostatistics, STAT programming, CRFs, Data Validation Plans

 

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.

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