Responsibilities:

• Provides the statistical input to the clinical trial protocols with respect to the study design, particularily the study objectives, endpoints, sample size, stratification and randomization
• Reviews and provides appropriate input to the design of Case Report Forms
• Performas statistical analysis using a variety of methods form simple univariate statistics to multivariate techniques
• Analyses and interprets statistics to point out relevant findings in relationships among sources of information and prepares conclusions based on these findings
• Prepares statistical summaries for presentation and/or submissions in the form og graphs, tables, written reports or listings.
• Acts as a statistical resource in the group and provides guidance to less experienced biostatisticians in choosing appropriate statistical design analysis methods
• A core member on clinical study teams to ensure adequate statistical advice and imput is provided to the clinical study teams through the different stages of clinical trials
• Defends the study designs and analyses to regulatory authorities when required
• Ensures the adherence to industry standards and regulatory requirements including but not exclusive to Good Clinical Practices (GCP) and ICH guideline on Statistical Principles for Clinical Trials
• Assists the Head of the Biostatistics and Data Management function with maintaining and updating the relevant statistical SOPs.

Qualifications:

* M.Sc. or Ph.D. in Statistics/Biostatistics.

*M.Sc. with five years or Ph.D. with two years experience in designing and analyzing clinical trials, preferably in house with a pharmaceutical company or a CRO.

*Sound knowledge of statistical/clinical trial methodology and commonly used statistical software, Strong SAS, R is a great asset

*Working knowledge of GCP requirements.

*Working knowledge of data standards (CDASH and CDISC) preferred.

Notes:

If possible, resumes should be submitted to us in MS Word format. Please note that although we appreciate your response to this job, we will only contact candidates who meet the exact hiring criteria identified by our clients.

**Please send resumes to lroberts@nevian.ca**

Liz Roberts

Director, Strategy & Business Development

Nevian Associates