Senior Principal CDISC Specialist (Remote)
Indianapolis, IN 
Share
Posted Today
Job Description
Job Overview:

Hiring forSenior Principal CDISC Specialist (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 Guidesto support SDTMs and ADaMs
Develop and/or lead the development of complex specifications for SDTMs and ADaM
datasets and contribute to the development of Covance by Labcorpand Client standards
Review SAPs and TFL shells from a programming perspective for studies and advise on thedevelopment of complex TFL shells from a programming perspective
Mentor programmers in the processes around SDTMs, ADaMs and TFLs and Study Leadprocesses, 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 ofstatistical programming

Education/Qualifications:

Recommended:

  • BSc, preferably in computing, life science, mathematical or statistical subject
Experience:

Minimum Required:

  • Typically 8 years of SAS programming experience in the CRO or Pharmaceutical industry, or anequivalent combination of education and experience to successfully perform the key responsibilities of the job
  • Deep knowledge of CDSIC (SDTM/ ADaM standards)

  • 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

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran). Your confidentiality and privacy are important to us.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
8+ years
Email this Job to Yourself or a Friend
Indicates required fields