- 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 SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
- Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and Reviewers Guides to support SDTMs and ADaMs
- Develop specifications for SDTMs and ADaM datasets
- Review SAPs and TFL shells from a programming perspective for studies
- Mentor less-experienced 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
- Identify processes within programming that will increase productivity, quality and efficiency
Graduate or Bachelor’s degree in Life Sciences (or Pharma or related health discipline) from an accredited university or college.
- 2-10 years experience as Statistical Programmer for Management and reporting of clinical trial data.
- Demostrated skills in the use of SAS, SDTM,ADaM and TFL.
- Good time management skills and the ability to work to tight deadlines while maintaining the highest standards of work.
- Awareness and appreciation of the business needs of a CRO.
- Effective communication skills.
- Cooperative and team oriented approach.
- Self motivation and ability to work independently.
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