Principal Statistical Programmer (Medical Devices)

<ul><li>Principal Statistical Programmer r<span>equired to work for Labcorp Drug Development in a Lead role</span></li><li>Working with multiple Sponsors across several therapeutic areas within medical devices</li><li>This is a permanent full-time role, either office based or home based anywhere in Central and Eastern Europe or in South Africa</li><li>You must have some previous experience of Leading studies as a Statistical Programmer in either a biotech, CRO or pharma company</li></ul><p></p><p>Join our growing team and discover your extraordinary potential by working as a Labcorp Drug Development <b>Principal Statistical Programmer</b><b>.  </b>You will enjoy a varied role working for different sponsors across several therapeutic areas within medical devices, leading projects and mentoring junior members of the department.  The position offers an excellent support network, flexible working solutions and the opportunity to progress your career.  If you are looking to strengthen your Lead expertise within a varied and dynamic environment, then this is a fantastic opportunity. </p><p></p><p><b><u>Job Primary Functions</u></b></p><ul><li>Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client</li><li>Develop, maintain, and validate SAS programs to create complete SDTM and ADaM datasets/analysis files, as well as TLFs</li><li>Perform QC of SDTM, ADaMs and TFLs</li><li>Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs</li><li>Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of company and Client standards</li><li>Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective</li><li>Mentor less-experience programmers in the processes around SDTMs, ADaMs and TFLs ensuring adherence to department practices and processes</li><li>Prepare and validate submission packages, e.g., define.xml, Reviewer's Guide</li><li>Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming</li></ul><p></p><p><b><u>Job Qualifications</u></b></p><ul><li>Bachelor’s degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects.</li><li>Medical Device experience preferred</li><li>Experience as lead statistical programmer on complex studies in clinical research</li><li>Knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management.</li><li>Broad knowledge of all CDISC requirements related to SDTM and ADaM, including Pinnacle 21, define.xml, Reviewer's Guide, submission standards, data structures and their implementation</li><li>You must be fluent in English language (both verbal and written)</li></ul><p></p><p><span>Looking to kick-start your career dedicated to improving health and improving lives? Then </span>#JoinThePursuit.</p><p></p><p><b>MORE INFORMATION AVAILABLE ON REQUEST</b></p><p>For a confidential discussion about this opportunity, please phone Peter Lewis on +447917710602 To apply, please click on the APPLY button. </p><p></p><p>NO AGENCIES PLEASE</p><p></p><p><b><u>Keywords:</u></b></p><p>Labcorp Drug Development, Covance By Labcorp, Covance, Chiltern, Statistical Programmer, SAS Programmer, Senior Statistical Programmer, Senior SAS Programmer, Lead Statistical Programmer, Lead SAS Programmer, Principal Statistical Programmer, Principal SAS Programmer,  Bloemfontein, Sofia, Prague, Budapest, Vilnius, Warsaw, Bucharest, Bratislava, home based, field based, home-based, flexible location, CDISC, medical device, devices, CEE, Central and Eastern Europe, Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Serbia, Slovakia, South Africa, #LI-PL1, #LI-Remote, Remote, EMEA</p><p></p><p><b>Labcorp is proud to be an Equal Opportunity Employer:</b></p><p></p><p>As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.</p><p></p><p>For <span>more information about how we collect and store your personal data, please see our </span><span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank">Privacy Statement</a></span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank"><span>.</span></a><span> </span></p>