Role:                     Biostatistician 
    Company:           CRO
    Location:             UK
 
 

Our client is world leading CRO with a reputation based on strongly held
core values and excellence in devloping client relations.

 

They have a global infrastructure spanning three continents and have a
commitment to long term development - both in terms of their business
but also in terms of those they employ.

 

 

Function: 

. Adherence to SOPs, Guidelines and all appropriate regulations. 
. To provide statistical input into design, analysis and reporting of
clinical trials 
 
 
Scope of Responsibility: 

. To be responsible for some aspects of statistical input for the
design, analysis and reporting of a project according to contracted
services in compliance with current legislation, ICH GCP and appropriate
company/Sponsor procedures and quality standards. 
 
. May have the responsibility to manage Data Division only projects or
to act as a Project Biostatistician (PBS) for the Statistical part of a
project. 
 
. May act as a mentor to less experienced Biostatisticians and assist in
their development and training. 
 

Major Tasks: 

. May be statistical representative on project teams. 
 
. Review and/or input to protocols, CRFs, database design and validation
specifications under the supervision of a more senior Biostatistician. 
 
. Preparation of statistical analysis plans, including template tables,
listings and figures, in accordance with SOPs, Sponsor specifications
and Industry Guidelines under the supervision of a more senior
Biostatistician. 
 
. Perform and/or supervise programming of tables, listings, figures and
statistical analyses according to agreed timelines and quality
standards. 
 
. Quality control of statistical programs produced by other members of
the department, including tables, listings, figures, complex
calculations and statistical analyses. 
 
. May produce randomisation schedules. 
 
. Quality control of the unblinding of a study database. 
 
. Statistical input to clinical trial reports including QC of sections
of the clinical trial report. 
 
. Maintain awareness of issues relating to the presentation of clinical
trials data, including general issues, regulatory views and Sponsor
specific activities. 
 
. Maintain awareness of quality issues relating to data representation
and accuracy. 
 
. Maintenance and archiving of statistical files. 
 
. Assisting in the development of SOPs and Working Procedures. 
 
. Maintain awareness of statistical issues related to clinical trials. 
 
. Any other task assigned by Manager 
 
 
Essential Competencies: 
 
. Disciplined Work Approach - Approaches work methodically and
systematically. Plans activities and organises time efficiently to meet
project timelines. Establishes priorities from among a number of
demands. Establishes a planned work approach, which is efficient and
concentrates on getting the task completed on time to a defined quality.

 
. Communication - Communicates clearly and confidently and has excellent
interpersonal skills. Has a strong awareness of the impact of own
behaviour on others and responds appropriately to achieve results. 
 
. Statistical Knowledge - Can apply statistical principals to clinical
trial situations. Has a broad understanding and experience analysing
medical data. 
 
. Attention to Detail - Committed to achieving good quality work and
striving to set higher standards and continually trying to achieve them.

 
. Computer Skills - In depth understanding of data structures and SAS
programming language. 

. Language Skills - Good written and verbal English language skills. 
 

Qualifications / Education: Minimum of a degree in
statistics/biostatistics or equivalent 
 
Previous Relevant Work Experience / Years of Experience: 
 
It is expected that for this role a minimum of 18 months previous
experience analysing data and programming in SAS is required.
Additionally a knowledge of the drug development process is needed.

 
If you feel that this position could offer you a chance to develop your
career then feel free to forward us a copy of your CV in order to
facilitate a further confidential discussion.


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AspirionPharma Ltd - Who are We?
 
AspirionPharma is a niche executive search firm specialising in the
provision of recruitment solutions to the global bio/Pharma and CRO
sectors. 
 
Utilising a developed and tested methodology we are able to provide
delivery on projects that other firms simply cannot.
 
Furthermore, we are positioned to provide additional "value-added"
benefits to our clients by acting as their "agents in the field" and
providing relevant industry information. We also ensure that they are
kept up to date (and in contact) with UQIs and industry leaders; this is
done through a tried and tested system of "Talent management".
 
We aim to provide a consultative approach to both clients and candidates
and will only proceed if we are sure that a prospective move will not
only aid fulfilling our clients strategic aims, but its also matches and
exceeds the expectations of our candidates.
 
Targeting only real market leaders, we are well aware how crucial it is
to fully understand the true aspirations of each individual before
acting on their behalf. It is this commitment to quality, combined with
an information led approach and developed methodology that sets us apart
from the mainstream.
 
Whether you are an industry leading individual or a firm wishing to take
the next step in your development let AspirionPharma help you achieve
your aspirations.
 
 
 
www.aspirionpharma.com
Aspirion (London)
Aspirion Ltd


 

 

 

Ash Butt LL.B Law (Hons) | Managing Director | AspirionPharma 

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