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Background: Biologics company focused on the research, development and manufacture of novel vaccines. A leading presence in the industry with a strong financial position, exciting developmental pipeline and experienced management team. A fantastic opportunity for an Associate Director or Director level Statistician to take responsibility for the set up and design of the Biostatistics/Statistical group. Salary up to £80K with excellent benefits. Primary Duties: Reporting directly to the Medical Director, you will take responsibility for Biostatistical activities within Clinical Development and Clinical Operations. Provide input to the clinical team on study design in initial clinical development plans, including planning for subject numbers and randomization strategy. Accountable for statistical analysis plans and statistical analyses. Supervising contractors where necessary. Accountable for statistical sections within protocol concept sheets, protocols, clinical study reports and other clinical documents, including clinical sections of regulatory documents. Provide randomizations for clinical trial supplies. Accountable for ensuring data transfers are performed in an appropriate and validated format. Provide ad hoc and post hoc exploratory analyses to support planning for future activities. Ensure that in house and CRO processes and systems are adequate to support regulatory Statistical activities (including data management systems and statistical analysis software programming). Provide support to other development functions (manufacturing development, preclinical etc) as required and subject to availability. Experience and Qualifications: PhD or equivalent in Biostatistics preferred or MSC in Biostatistics/Medical Stats. If you do not have these qualifications then excellent experience may be suitable. You will currently be Associate Director or Director level within Pharmaceutical or Biotechnology industry Clinical Biostatistics. Good interpersonal skills are essential for working in multiple teams. Contact: * Christian Simon - Resource Executive * Tel: 020 8560 2300 * Send your CV quoting job ref 2007 * AXESS Limited, Parkshot House, 5 Kew Road, Richmond, Surrey. TW9 2PR Disclaimer: * This e-mail is confidential and may be legally privileged. If received in error, you should inform the sender * immediately and should not disclose the e-mail without authorisation from AXESS Limited or use the * information contained for your own purposes. Christian Simon Resource Executive christian.simon <mailto:[log in to unmask]> @axess.co.uk (+44) 020 8560 2300 AXESS Limited Resourcing Solutions for Clinical Development & Medical Affairs Parkshot House, 5 Kew Road, Richmond upon Thames, Surrey TW9 2PR Tel. 020 8560 2300 Fax: 020 8560 2033 www.axess.co.uk Company registration no: 2868143 This e-mail is confidential and may be legally privileged. If received in error, you should inform the sender immediately and should not disclose the e-mail without authorisation from AXESS Limited or use the information contained for your own purposes.