CONTRACT: 2 x Statistical Programmer
Department of Biostatistics & Epidemiology
Based in the UK - 6 month rolling contract
Job Summary:
Working for this major client, you will ensure;
* all programming outputs pertaining to individual clinical
studies and ISS/ISE meet required standards and are validated / correct
* all programming outputs pertaining to non-registrational
activities meet required standards and are validated and correct
* quality and accuracy of programming deliverables.
Accountabilities/Responsibilities:
* Assist in the recruitment of programming staff
* Provide support to (mentor) more junior programmers
* Participate in technical programming and process improvement
initiatives within Global Biostatistics
* Function as a Project Lead Programmer with the following key
activities:
* Represent the programming function and, as required,
participate in multidisciplinary team meetings
* Project-manage all programming activities on the program,
according to agreed resource and timeline plans
* Ensure all programming activities on the program adhere to
departmental standards
* Create or review/approve all programming plans at study and
program level
* In Clinical Development, may be a global role
* Set up study level programming environment
* Generate randomization lists
* Draft SDF dataset specifications
* Review and approve SDF dataset specifications drafted by another
programmer
* Review and approve key study-related documents produced by other
functions (e.g. CRF, Data Management Plan etc)
* Review SAPs from the programming perspective
* Draft programming plans
* Review and approve programming plans drafted by another
programmer
* Write, test and validate software programs to produce SDF and
analysis datasets and TLGs for inclusion within CSRs, ISS / ISE,
publications and other communications
* Perform QC checking of software programs written by another
programmer
* Manage software development, testing & release in a Unix
environment
* Understand and execute department-level, program-level and
study-level macros and utilities
* Write, test, validate department-level, program-level and
study-level macros and utilities
* Oversee the work of outsourcing partners and vendors at study
level
* Contribute to Requests for Proposals (RFPs) from outsourcing
vendors for programming services
* Participate in the development and review of Company Policies,
SOPs and other controlled documents
* Participate in study and systems audits by Client CQA and
external bodies, and respond to audit questions and findings
* Provide input to and participate in intra-departmental and
global Biostatistics meetings
* Promote and communicate awareness of biostatistical programming
and the role of the Biostatistics department (internal/external;
scientific/process)
* Contribute to the continuous improvement of Global Biostatistics
and Development
Essential Skills & Capabilities:
Educated to BS/BSc or higher degree in Computer Science, Statistics,
Mathematics, Life Sciences or other relevant scientific subject your
knowledge will encompass;
* Biostatistical Programming using the SAS System
* Clinical Trials within Pharmaceutical/Biotechnology/Public
Health setting in Industry, Government or Academia
* Drug Development (Pre-clinical Development, Clinical
Development, Medical Affairs)
* Project Planning and Management
* Development of policies and SOPs
* International co-operation
* Team working
* Minimum 3 years' relevant career experience
An excellent opportunity awaits for this renewable contract. Interview
times booked and full job specification to review...
If you would to discuss this role in greater detail or your application
/ suitability to this or further roles, please call me or email me in
confidence. If you are not available or suited to this position, please
feel free to pass my details on.
We also have a broad variety of other Biometric specific vacancies
available in the UK and throughout Europe. Inclusive of SAS programming,
Statistical, Clinical programming, Data Management functions, Regulatory
Affairs, Clinical Research, QA, Compliance & Validation.
For a confidential consultation call James Carrera on 0044 (0) 207 255
6665 or email your CV to [log in to unmask]
Anticipating your response.
James Carrera
European Contracts Manager
Pharmaceutical, Healthcare & CRO division
1st Pharma People
"A Division of 1st IT People"
Tel: +44 (0) 207 255 6665
Fax: +44 (0) 207 255 6656
[log in to unmask]
www.1st-pharmapeople.com
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