Statistical Programmer in Oncology - Boston, MA
Aixial is recruiting a consultant for statistical programming in Oncology :
- To develop analysis data sets (ADAM)
- To prepare submission package
- To develop statistical programs of analyses for CSR, summary documents, regulatory activities
- To participate in the creation of regulatory documentation (programming specifications, define,…)
- To participate in answers to questions from regulatory activities
- As described in the objectives, the mission will be to develop programs for the production of data sets analysis and statistical analysis for oncology studies.
- The mission will be supervised by the statistical programming team leader or US biostatistics team leader.
- The expected deliverables are :
- Analysis programs
- Validation programs
- Documentation associated to programming
- Master in biostatistics with at least 2 years of experience as biostatistician or programmer in the context of clinical trials and therapeutic development in oncology
- Proficiency in SAS software programming,
- Experience CDISC (SDTM/ADaM in particular),
- Experience in FDA submission
Our client is based in Boston.