Senior SP ≥5 years/ Principal ≥7 years SP 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.
1.Perform the role of the Lead Statistical Programmer.
2.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.
3.Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs.
4.Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and
5.Reviewers Guides to support SDTMs and ADaMs.
6.Develop specifications for SDTMs and ADaM datasets.
7.Review SAPs and TFL shells from a programming perspective for studies.
8.Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs.
9.Present and share knowledge at department meetings.
10.Respond to QA and client audits, and support qualification audits.
11.Identify processes within programming that will increase productivity, quality, and efficiency.
12.All other duties as needed or assigned.
Qualifications (Minimum Required):
1.Bachelor’s degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects.
2.Experience and/or education plus relevant work experience, equating to a Bachelor's degree.
3.Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Language Skills Required:
1.Speaking: Yes, English required
2.Writing/Reading: Yes, English required
Experience (Minimum Required):
1.Typically,
Senior SP ≥5 years/ Principal ≥7 years SP 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.
2.Previous lead experience in medium/complex study, prefer global II/III experience
3.Knowledge of CDISC requirements.