Principal Statistical Programmer (Remote)

Covance King Of Prussia , PA 19406

Posted 2 months ago

Job Overview:

Hiring for Principal Statistical Programmer (Remote) FSP: can be based anywhere in USA/ Canada #LI-REMOTE

  • Perform the role of the Lead Statistical Programmer.

  • 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 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 less-experience programmers in the processes around SDTMs, ADaMs and TFLs 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 to proposal activities and participate in bid defenses meetings in order to win new 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 6 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

  • Experience as lead statistical programmer on complex studies in clinical research

  • 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.

  • Broad knowledge of all CDISC requirements related to SDTM and ADaM, including

define.xml, Reviewer's Guide and submission standards

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Principal Statistical Programmer (Remote)

Labcorp

Posted 2 months ago

VIEW JOBS 11/4/2021 12:00:00 AM 2022-02-02T00:00 Job Overview: Hiring for Principal Statistical Programmer (Remote) FSP: can be based anywhere in USA/ Canada #LI-REMOTE * Perform the role of the Lead Statistical Programmer. * 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 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 less-experience programmers in the processes around SDTMs, ADaMs and TFLs 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 to proposal activities and participate in bid defenses meetings in order to win new 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 6 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 * Experience as lead statistical programmer on complex studies in clinical research * 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. * Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards Labcorp King Of Prussia PA

Principal Statistical Programmer (Remote)

Covance