Lead Statistical Programmers

<ul><li><b>Lead Statistical Programmers</b> <span>required to work for Labcorp Drug Development</span></li><li>Permanent, full time roles, 0.8 FTE considered</li><li>We can hire at the following job titles:<ul><li>Senior Statistical Programmer</li><li>Principal Statistical Programmer</li><li>Senior Principal Programmer</li></ul></li></ul><ul><li>We have opportunities working within the following business units:<ul><li>CPS – Clinical Pharmacology Services – Phase I Healthy Volunteer Studies, Multiple Therapy Areas, Multiple Sponsors</li><li>CDS Oncology – Clinical Development Services - Phase I & II Patient Oncology Studies, Multiple Sponsors</li><li>CDS Late Phase – Clinical Development Services - Phases II-IV, Multiple Therapy Areas (including oncology), Multiple Sponsors</li><li>FSP – Functional Service Provision - Working dedicated to 1 Sponsor, various opportunities in early and late phase, oncology and non-oncology.  Some FSP agreements mean you are outsourced to Sponsor, others you work internally</li></ul></li><li>Office based or home based anywhere in these countries:<ul><li>Austria</li><li>Belgium</li><li>Bulgaria</li><li>Czech Republic</li><li>Estonia</li><li>France</li><li>Germany</li><li>Greece</li><li>Hungary</li><li>Ireland</li><li>Italy</li><li>Latvia</li><li>Lithuania</li><li>Netherlands</li><li>Poland</li><li>Portugal</li><li>Romania</li><li>Serbia</li><li>Slovakia</li><li>South Africa</li><li>Spain</li><li>Sweden</li><li>UK</li><li>Ukraine</li></ul></li><li>You must have previous Lead Statistical Programmer experience gained within a biotech, CRO or pharma company</li><li>Candidates must be fluent in English language (both verbal and written) and have the automatic right to work in the relevant country</li></ul><p></p><p><b><u>Job Primary Functions for Senior Statistical Programmer</u></b></p><ul><li>Perform the role of the Lead Statistical Programmer<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, etc.</li></ul></li><li>Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs</li><li>Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and Reviewers Guides to support SDTMs and ADaMs</li><li>Develop specifications for SDTMs and ADaM datasets</li><li>Review SAPs and TFL shells from a programming perspective for studies</li><li>Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs</li><li>Present and share knowledge at department meetings</li><li>Respond to QA and client audits, and support qualification audits</li><li>Identify processes within programming that will increase productivity, quality and efficiency</li></ul><p></p><p><b><u>Job Primary Functions for Principal Statistical Programmer</u></b></p><ul><li>Perform the role of the Lead Statistical Programmer.<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, etc.</li></ul></li><li>Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and 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>Present and share knowledge at department meetings</li><li>Respond to QA and client audits and support qualification audits</li><li>Contribute to proposal activities and participate in bid defenses meetings in order to win new business</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 Primary Functions for Senior Principal Statistical Programmer</u></b></p><ul><li>Perform the role of a Lead Statistical Programmer including leading oversight of partnership programs<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, etc.</li></ul></li><li>Develop and maintain SAS programs to create complex SDTM and ADaM datasets and TFLs, and 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 Covance 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 programmers in the processes around SDTMs, ADaMs and TFLs and Study Lead processes, ensuring adherence to department practices and processes</li><li>Facilitate advanced technical expertise</li><li>Respond to QA and client audits and represent the department in all types of audits</li><li>Participate in partnership Bid Defenses in order to win new packages of business</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>BSc, preferably in computing, life science, mathematical or statistical subject</li><li>You must have some previous experience of working as a Lead Statistical Programmer in either a biotech, CRO or pharma company using SAS.</li><li>Knowledge of CDISC requirements</li><li>Positive attitude and willingness to learn and contribute in a team setting and communicate effectively within the team environment</li><li>Good organization skills and the ability to prioritize own work</li><li>Self motivation and ability to work independently</li><li>A cooperative and team-oriented approach</li><li>Candidates must be fluent in English language (both verbal and written)</li></ul><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>