Senior Principal Statistical Programmer (Remote): FSP

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Posted 11 days ago United States Salary undisclosed
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Job Description

Job Overview:

Hiring for Senior Principal Statistical Programmer (Remote): can be based anywhere in USA/ Canada

* Perform the role of a Lead Statistical Programmer including leading oversight of partnership programs
* 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 complex SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
* Produce 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 Labcorp Drug Development 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 programmers in the processes around SDTMs, ADaMs and TFLs and Study Lead processes, ensuring adherence to department practices and processes
* Facilitate advanced technical expertise
* Respond to QA and client audits and represent the department in all types of audits
* Participate in partnership Bid Defenses in order to win new packages of business
* Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming

Education/Qualifications:

Minimum Required:

* Bachelor's degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects.
* Experience and/or education plus relevant work experience, equating to a Bachelor's degree

Experience:

Minimum Required:

* 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
* Extensive experience as lead statistical programmer on complex studies in clinical research
* Substantial knowledge of all aspects of clinical trials from initial study set-up to study completion.
* 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.
* Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards