Principal Statistical SAS Programmer, single sponsor-dedicated - home- or office-based at Labcorp Drug Development

As an expert Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex clinical trials (phases I-III) for renowned, innovative and global top pharmaceutical companies. You will be responsible for all statistical programming deliverables of one or more complex clinical trials. 

This position allows you to participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas such as oncology, cardiovascular, respiratory, neurological, diabetes, rare diseases, pain, immunology etc. Your expertise as a Principal Statistical Programmer has a direct impact on improving the health and lives of thousands of patients around the globe every day.

Your responsibilities:

• 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.
• Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform quality control reviews of SDTM, ADaMs and TFLs
• Produce and/or define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
• Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets, and contribute to the development of company and client standards
• Review SAPs and TFL shells from a programming perspective for studies, and advise on the development of complex TFL shells from a programming perspective
• Mentor less-experienced team members in best practices around SDTMs, ADaMs and TFLs while ensuring adherence to department practices and processes
• Present and share knowledge at department meetings
• Respond to QA and client audits and support qualification audits
• Contribute your expertise to proposal activities and bid defense
• Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming

Your profile:

• Degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
• In lieu of the above: an equivalent completed vocational training and / or equivalent professional experience in statistical programming for drug development
• Profound professional experience as a lead statistical programmer working on complex studies within a biotech, CRO or pharmaceutical company
• 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
• Expert knowledge of base SAS, SAS macros, SAS/STAT and in debugging SAS programs
• Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards
• Solid experience with oncology and/or vaccine clinical trials and the corresponding datasets (safety and efficacy) and endpoints
• Excellent organizational, time management and project management skills with demonstrated leadership skills
• Outstanding problem solving and decision making skills, coupled with a proactive approach - anticipating issues and working to ensure they are avoided or resolved as quickly as possible
• An autonomous, collaborative work style, a curious mind and a keen attention to detail
• Business fluency in English – both verbal and written – is a must