- Consultant will be writing statistical analysis plans, analyzing clinical study data, contributing statistical sections to a final study report (including table and listing appendices, report results sections, graphs, etc.) and IND Annual Safety Reporting
- Will also include working with the team to resolve reporting issues, trouble-shooting of complicated analysis rules, proactive identification of problems, and attendance at study meetings
- Must have excellent communication skills and work well in a study team environment that includes SAS programmers, data managers, clinical, and regulatory colleagues
- Experience coordinating work assignments with a CRO is a plus, but not necessary
- Pharmaceutical research oncology experience in the US is a plus, but not necessary
- A PhD or MS in Statistics with at least 3 years pharmaceutical experience in an FDA regulated environment covering Phases II-IV
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