CONTRACT: Statistical SAS 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
1st IT People Limited is acting as an Employment Agency and/or Employment Business
James Carrera
Tel: +44 (0) 207 255 6665
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http://www.justgiving.com/jamescarrera
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