JOB SUMMARY: Capable of leading a clinical study with some support and oversight, with working knowledge of FDA regulations and general industry standards. Further develop technical and infrastructure support skills.
This will be a 1 year contract with extensions. Must be able to work on-site.
DETAILED DUTIES & RESPONSIBILITIES TYPICALLY INCLUDE:
Support other statisticians by cleaning data, creating exploratory tables and listings, reviewing output, and validating analyses
Perform sample size and power calculations
Review CRFs and edit checks
Develop SAP and create table, listing, and figure shells
Validate statistical analysis as defined in SAP
Able to code statistical analyses and familiar with good coding practices
Provide biostatistics support for study team
Assist in interpretation and writing of results
Support preparations for interactions with regulatory agencies
Read and understand Medical/Clinical literature as required by duties
Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems.
Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
MS in Statistics, Biostatistics, Epidemiology or related field
1+ years of experience in in pharmaceutical/biotechnology clinical trials or related environment
Working knowledge of FDA regulations, ICH GCP guidelines, the drug development process
Good programming skills and knowledge of SAS
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