Act as the analyst for Non-Interventional Studies (NIS)
Contribute to the writing of the standard NIS documents (including protocol development, iAP development and study report writing)
Write programs needed for the analysis and execute the analysis
Contribute to the report of study results and its interpretation
Contribute to the critical review of publications, and study proposals from internal and external sources
Understand and follow all Global Epidemiology-related SOP/ WIs and relevant Standards as well as any other relevant internal documents
Contribute actively to achievement of team goals
Participate in the assessment of possible RW data sources to be licensed-in/ purchased and of analytical tools
Who you are:
At least 3 years experience in the Pharmaceutical/ Biotechnology industry in analyses of large RW datasets from automated healthcare databases (EMR and/ or claims data) or RW field studies is preferred
Working experience with SAS /R
Knowledge of relevant regulatory guidelines applicable to NIS, and more specifically to post authorization safety/efficacy studies
Knowledge of coding systems used in healthcare and pharmacovigilance databases (e.g., ICD 9/ 10, CPT, HCPCS, READ codes, ATC classification, MedDRA)
Familiarization with or ability to develop an understanding of relevant therapeutic areas
