About this role
Role Overview
- Perform the role of the Lead Statistical Programmer.
- Plan, execute and oversee all programming activities on a study.
- Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs.
- Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides.
- Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets.
- Review SAPs and TFL shells from a programming perspective for studies.
- Mentor less-experience programmers in the processes around SDTMs, ADaMs and TFLs.
- 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.
Requirements
- 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.
- Typically, 6 years of SAS® programming experience in the CRO or Pharmaceutical industry.
- 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.
- Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards.
- Speaking: Yes, English required
- Writing/Reading: Yes, English required.
Benefits
- Health insurance
- Flexible work arrangements