Sr Biostatistician (Consultant), Orange County, Submissions experience
An exciting biotech company based in Orange County, CA urgently requires a Sr Biostatistician with recent CDISC, SDTM and ADaM data structure experience on a 6-12 month contract.
You will meet the following requirements:
2+ years of industry oncology experience as a Biostatistician Produce and QC statistical analysis plans and reports for Phase I and II oncology studies
Use SAS to produce and QC analysis (derived) datasets, descriptive and non-descriptive analysis tables, listings, graphs, and statistical tests as outlined in the statistical analysis plan and / or protocol
Work to the specifications in related SOPs, sponsor requirements, and GCP guidelines.
Provide statistical input into oncology clinical study designs and protocols (such as sample size calculations, randomization, statistical methodology)
Input into eCRF/CRF development.
Review and provide input into clinical study reports.
Please apply ASAP with an up to date-resume if you are interested.
Key Words: Biostatistician, Biostatistics, Statistics, SAS, Orange, County, san, Diego, CA, California, FDA, NDA, Submissions, CDISC, SDTM, ADaM, Data, Structure, Sets, Reports, Tables, Analysis, Protocol, Oncology, Clinical, Study, eCRF, CRF