My client:
As one of the world's leading research based pharmaceutical companies a
culture of innovation is central to my clients continuing success. As a
result, they are able to boast a rich pipeline of products in development.
My clients focus is on delivering the best outcomes for people, patients and
their products is unwavering.
My client are a successful business that can offer exciting career
opportunities, both locally and internationally, in a supportive and
rewarding culture.
The Role:
The Senior Programmer provides statistical software and software
documentation support to biostatistics in general and to specific clinical
projects. They will take responsibility for the planning, development,
validation, documentation and maintenance of generic tools (across project
programs) ensuring that the objectives, standards, deadlines and other
requirements set by Biostatistics management with respect to statistical
software and its documentation and validation are attained. They will also
provide technical support in usage of SAG tools, give advice on SAS software
usage and problem solving and deputise upon request for the Project
Programmer.
Principle functional responsibilities:
General Responsibilities
* Provides technical advice and support to biostatisticians.
* Assesses, recommends and develops new standards, policies and
procedures.
Assesses, develops and documents new
* methods and software.
* Keeps abreast of statistical programming methodology and application
and software developments through literature and attendance at meetings.
Maintains familiarity with regulatory authority guidelines relating to
biostatistics, data reporting and medical issues in project areas.
* Maintains proficiency with respect to in-house computer facilities
and software.
* Interacts with Data Management and Biostatisticians to ensure good
communication.
* Makes presentations at professional forums.
Statistical Software Standards
* Develops and documents statistical programming standards in
accordance with current statistical programming practices and regulatory
authority requirements.
* Programs, validates and documents software in SAS following
statistical programming standards and ensures its availability to users.
Whenever creating new software, ensures the efficient use of existing
software.
Tool Development
* Takes responsibility for planning, development, validation,
documentation and maintenance of generic tools.
* Estimates resource requirements for a tool development project.
* Informs and makes recommendations to the Project Programmer on
critical issues within a tool development project.
* Coordinates internationally plans and tasks for a tool development
project.
* Trains users to apply generic tools. Assists users to resolve
individual technical difficulties with the generic tools.
Drug development
Ensures that programming activities performed within the project are
executed in a timely manner and to the required high reporting standards.
* Interacts with other members of Biostatistics Team to clarify
programming requirements and to give advice on the availability of standard
programs and the cost/effectiveness of developing new software.
* Assists in the development of trial protocols, trial analyses,
editing procedures and data presentations relating to efficacy and safety
data and availability under the direction of the responsible project
statistician.
* Creates the datasets specification according to the Generic Data
Model in cooperation with clinical programming.
* Provides SAS datasets to the Biostatistics Team in the format
required for special evaluations.
* Programs, validates and documents data tabulations, graphics and
statistical evaluations for efficacy and safety. Ensures that programs
developed for specific projects/protocols are sufficiently portable to allow
application to other projects and protocols.
* Performs analyses of efficacy and safety data, generates tabulations
and graphs and provides them to members of the Biostatistics Team.
* Maintains up-to-date project documentation including that of
presentation, analysis and graphics software.
Verifies adherence to Biostatistics coding and validation standards and SOPs
within the project.
WHO YOU ARE;
* BSc, MSc or PhD (or equivalent) in Statistics, Computer Science,
Mathematics or other analytical field.
* At least 5 years pharmaceutical industry drug development experience
using SAS
* Good knowledge of international clinical research and drug
development.
* Experience in programming and using statistical software as well as
knowledge of databases and interface systems. Very good knowledge of SAS.
* Travel may be required
If you are interested in this position, please contact me for review of the
full specification.
If you know of anyone to which this is applicable but may not receive this
email, please feel free to forward this email to relevant persons.
Mathew Hogan
Senior Consultant
Pharmaceutical, Biometrics & CRO Division
1st Pharma People
A Division of 1st-IT People
Tel: +44 (0) 207 255 6665
Fax: +44 (0) 207 255 6656
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People, 3rd Floor, Woolverstone House, 61-62 Berners Street, London. W1T
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6665. Please note our previous phone number will still work.
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