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> Dear Allstat > > Please find the latest permanent vacancy for a Senior Biostatistical Programmer position within a Global Biotechnology company based in the UK. > > Senior Biostatistical Programmer Purpose * Write, test and validate software programs to support the regulatory approval process or non-registrational activities * To function as a Project Lead Programmer The Senior Biostatistical Programmer Analyst: * Is a regional role within US Clinical Development Biostatistics or US Medical Affairs Biostatistics or EU Biostatistics * Is a global assignment within Clinical Development when a Senior Biostatistical Programmer Analyst functions as a Project Lead Programmer Responsible for: * Ensuring all programming outputs pertaining to individual clinical studies and ISS/ISE meet required standards and are validated and correct * Ensuring all programming outputs pertaining to non-registrational activities meet required standards and are validated and correct * Adhere to all Policies, SOPs and other controlled documents Key Activities · Assist in the recruitment of programming staff 1 Provide support to (mentor) more junior programmers 2 Participate in technical programming and process improvement initiatives within Global Biostatistics 3 Function as a Project Lead Programmer with the following key activities: · Represent the programming function and, as required, participate in multidisciplinary team meetings 171 Project-manage all programming activities on the program, according to agreed resource and timeline plans 172 Ensure all programming activities on the program adhere to departmental standards 173 Create or review/approve all programming plans at study and program level 174 In Clinical Development, may be a global role · Set up study level programming environment 1 Generate randomization lists 2 Draft SDF dataset specifications 3 Review and approve SDF dataset specifications drafted by another programmer 4 Review and approve key study-related documents produced by other functions (e.g. CRF, Data Management Plan etc) 5 Review SAPs from the programming perspective 6 Draft programming plans 7 Review and approve programming plans drafted by another programmer 8 Write, test and validate software programs to produce SDF and analysis datasets and TLGs for inclusion within CSRs, ISS / ISE, publications and other communications 9 Perform QC checking of software programs written by another programmer 10 Manage software development, testing & release in a Unix environment 11 Understand and execute department-level, program-level and study-level macros and utilities 12 Write, test, validate department-level, program-level and study-level macros and utilities 13 Oversee the work of outsourcing partners and vendors at study level 14 Contribute to Requests for Proposals (RFPs) from outsourcing vendors for programming services 15 Participate in the development and review of Policies, SOPs and other controlled documents 16 Participate in study and systems audits by CQA and external bodies, and respond to audit questions and findings 17 Provide input to and participate in intra-departmental and global Biostatistics meetings 18 Promote and communicate awareness of biostatistical programming and the role of the Biostatistics department (internal/external; scientific/process) 19 Contribute to the continuous improvement of Global Biostatistics and Development Preferred Role Qualifications, Experience, Knowledge & Competencies Qualifications * BS/BSc or higher degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject Experience * 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 5 years' relevant career experience Knowledge * Biostatistical Programming within Drug Development * Drug Development Process & Operations * English Key Competencies * Scientific / Technical Excellence * Problem Solving * Team Work * Attention to Detail * Project Management > For further information or to apply for this role send your details to Robert Whyte at James Harvard Pharmaceutical. > > Email [log in to unmask] or you can call directly on +44 (0) 20 7922 7117 > > If this opportunity is not what you are looking for but are actively looking for a contract or permanent position as a Biostatistician or SAS Programmer then call for a confidential discussion. > > Kind regards, > Robert Whyte Consultant ~ Clinical & Biometrics Division James Harvard Pharmaceutical Ltd T. 020 7922 7117 M. 07957 190569 F. 020 7922 7101 E: [log in to unmask] W: www.jamesharvardpharma.com 25 - 27 Wootton Street : Waterloo : London : SE1 8TG ______________________________________________________________________ This email has been scanned by the MessageLabs Email Security System. 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