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Biostatistician

Company:
inVentiv
Location:
Seattle, Washington, United States
Salary:
Based on experience
Posted:
December 09, 2016
Description:

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.

REQUIREMENTS:

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