Senior Statistician - Home Based

Key People


Job ID :

11819


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Oxfordshire,Oxfordshire,


Key Skills :

statistics, statistician, senior statistician, home based, SAS, clinical


Salary :

£45000 - £58000 per annum


Date Posted :

12 Jun, 2018



Company Name :

Key People


Location1 :

Oxfordshire




Job Category :

Scientific Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

Primary responsibilities:

*Leading biostatistics activities related to clinical trials
*Development and review of statistical sections of protocols, including sample size calculations
*Development of statistical analysis plans
*Development and documentation of analysis database structures (i.e. SAS analysis data set structures)
*Development of SAS program requirements and specifications
*SAS programming and program validation
*Review and QC of statistical deliverables (tables, listings, figures, etc.)
*Performing statistical analysis and reporting results
*Providing consultation on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products
*Liaison with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics

Communication:

*Communication line for project teams, including statisticians and SAS Programmers
*Communication line for customer on statistical questions
*Communication line for vendors on statistical questions

Training:

*Conduct of project-specific training of statisticians and SAS programmers
*Coaching and training of statisticians (non-project-related)
*Preparation and delivery of presentations at investigators' meetings

Quality Assurance:

*Preparation for and attendance at internal and third-party study audits pertinent to Statistics
*Preparation of the answers to the internal/external audits findings/recommendations, and follow-up on and resolution of audit findings
*Participation in the development of guidelines, procedures and other Quality Systems Documents (QSDs) pertinent to activities of the Biostatistics department

Experience:

*MSc in Statistics or equivalent
*At least 5 years of industry experience in clinical research
*At least 5 years of industry experience in biostatistics
*At least 5 years of experience in SAS programming
*Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
*Very Good knowledge and understanding of the SAS programming language
*Strong ability to apply a range of advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information
*Strong ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
*Strong ability to represent biostatistics in bid defenses
*Strong knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)

Skills:

*Excellent presentation and communication skills
*Advanced knowledge of SAS software
*Good knowledge of MS office software
*Advanced knowledge of CDISC ADaM IG 1.0 or later, define1-0-0.xml and define2-0-0.xml specifications
*Knowledge of CDISC SDTM IG 3.1.3 or later and nQuery Advisor software is a plus


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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