Biostatistician to provide statistical and strategic support related to clinical development plans, study designs, and analysis of data for analytical and clinical studies.

Project Description

Position Summary:

We are seeking an experienced and talented Biostatistician to provide statistical and strategic support related to clinical development plans, study designs, and analysis of data for analytical and clinical studies.

Principal Responsibilities and Duties:

Contribute to design of clinical trials with appropriate statistical methods and sample size to support regulatory submissions in the US and worldwide

Develop and execute data analysis plans, resulting in written reports with tables, listings and figures for regulatory submissions

Collaborates in the preparation and review of study protocols for clinical trials and analytical studies

Communicate project requirements for CRF design, database design and database cleanup to ensure the key study variables are suitable for analysis

Qualifications:

Formal Training/Education:

Master’s degree required, PhD preferred.

A minimum of 5 years relevant biostatistics experience

3-5 years medical diagnostic trials experience preferred

Experience and Required Skills:

Significant experience in analysis and reporting of study results using statistical software such as R, S-Plus, SAS or Stata

3-5 years biostatistics/data management and/or related work experience in in vitro diagnostic medical device or pharmaceutical development

Experience in 510(k) and PMA trial design and execution preferred

Design of Experiments (DOE) experience

Working knowledge of ICH guidelines, GCP, clinical research, clinical trial processes and related regulatory requirements and terminology

Detail-oriented, self-motivated, ability to work independently and in a team-oriented setting

Ability to effectively communicate verbally and in writing with project team members

Role will require travel and/or relocation for a 6 month period to Tuscon, Arizona.