Senior Principal CDISC Specialist (Remote)

<h2≥Job Overview:</h2≥<p style="margin: 0px;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥<strong≥Hiring for Senior Principal CDISC Specialist (Remote): can be based anywhere in USA/ Canada</strong≥</span≥</p≥<p style="margin: 0px;"≥ </p≥<p style="margin: 0px;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Perform the role of a Lead Statistical Programmer including leading oversight of partnership</span≥<br /≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥programs</span≥</p≥<p style="margin: 0px;"≥ </p≥<p style="margin: 0px;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Plan, execute and oversee all programming activities on a study, including but not</span≥<br /≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥limited to, resource estimation, working within budget, meeting timelines, maximizing</span≥<br /≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥quality, interaction with other departments and the client, etc.</span≥</p≥<p style="padding-left: 30px;"≥<br /≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥♦ Develop and maintain SAS programs to create complex SDTM and ADaM datasets and TFLs, </span≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥and perform QC of SDTM, ADaMs and TFLs</span≥<br /≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥♦ Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides </span≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥to support SDTMs and ADaMs</span≥<br /≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥♦ Develop and/or lead the development of complex specifications for SDTMs and ADaM</span≥<br /≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥datasets and contribute to the development of <span style="color: #000000;"≥Covance by Labcorp </span≥and Client standards</span≥<br /≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥♦ Review SAPs and TFL shells from a programming perspective for studies and advise on the </span≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥development of complex TFL shells from a programming perspective</span≥<br /≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥♦ Mentor programmers in the processes around SDTMs, ADaMs and TFLs and Study Lead </span≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥processes, ensuring adherence to department practices and processes</span≥<br /≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥♦ Facilitate advanced technical expertise</span≥<br /≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥♦ Respond to QA and client audits and represent the department in all types of audits</span≥<br /≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥♦ Participate in partnership Bid Defenses in order to win new packages of business</span≥<br /≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥♦ Continually identify and suggest ways to improve the efficiency, quality and productivity of </span≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥statistical programming</span≥</p≥<h2≥Education/Qualifications:</h2≥<p style="margin: 0px;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Recommended:</span≥</p≥<ul≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥BSc, preferably in computing, life science, mathematical or statistical subject</span≥</li≥</ul≥<h2≥Experience:</h2≥<p style="margin: 0px;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Minimum Required:</span≥</p≥<ul≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Typically 8 years of SAS® programming experience in the CRO or Pharmaceutical industry, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job</span≥</li≥<li≥<p style="margin: 0px;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥<strong≥Deep knowledge of CDSIC (SDTM/ ADaM standards)</strong≥</span≥</p≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Extensive experience as lead statistical programmer on complex studies in clinical research</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Substantial knowledge of all aspects of clinical trials from initial study set-up to study completion.</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Complete knowledge and understanding of the processes and procedures used within a Statistical</span≥<br /≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Programming environment and the ability to communicate to programmers and non-programmers</span≥<br /≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥alike.</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, </span≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Reviewer's Guide and submission standards</span≥</li≥</ul≥