Senior Principal Statistical Programmer (Remote): FSP

<h2>Job Overview:</h2><p style="margin-bottom: 0in;"><strong><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Hiring for Senior Principal Statistical Programmer (Remote): can be based anywhere in USA/ Canada</span></strong></p><p style="margin-bottom: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;"> </span></p><ul><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Perform the role of a Lead Statistical Programmer including leading oversight of partnership programs </span></li><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">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. </span></li><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Develop and maintain SAS programs to create complex SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs </span></li><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs</span></li><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Labcorp Drug Development and Client standards </span></li><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective </span></li><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Mentor programmers in the processes around SDTMs, ADaMs and TFLs and Study Lead processes, ensuring adherence to department practices and processes </span></li><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Facilitate advanced technical expertise </span></li><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Respond to QA and client audits and represent the department in all types of audits </span></li><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Participate in partnership Bid Defenses in order to win new packages of business </span></li><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming</span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0px;"> </p><p style="margin-bottom: 0in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Minimum Required: </span></p><ul><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Bachelor’s degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects.</span></li><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Experience and/or education plus relevant work experience, equating to a Bachelor's degree</span></li></ul><h2>Experience:</h2><p style="margin-bottom: 0in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Minimum Required:</span></p><p style="margin-bottom: 0in;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;"> </span></p><ul><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">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 style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Extensive experience as lead statistical programmer on complex studies in clinical research </span></li><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Substantial knowledge of all aspects of clinical trials from initial study set-up to study completion. </span></li><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Complete knowledge and understanding of the processes and procedures used within a Statistical Programming environment and the ability to communicate to programmers and non-programmers alike.  </span></li><li style="margin-left: 1.25in;"><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards</span></li></ul><p style="margin: 0px;"><span style="font-size: 12.0pt; font-family: 'Times New Roman',serif;"> </span></p>