o 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.
BSc,B.E , B.Tech, M.Tech, preferably in computing, life science, mathematical or statistical subject
- 2-10 years experience as Statistical Programmer for management and reporting of clinical trial data.
- Demostrated skills in the use of SAS.
- 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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