Scope of the Job:

This new position, located at US company headquarters in Chicago, IL reports to the Manager of Statistics. You will serve as the lead statistician for the analysis of clinical trials being conducted by the company. You will interact with the data management department, the clinical development department, and medical writing. Additionally, you will interact with the client to carry out the clinical trial. This job requires knowledge of statistics in clinical trials, SAS programming, good communication skills, and excellent attention to detail.

Responsibilities Include:

1. You will serve as the lead statistician on project teams for the execution of clinical trials. This includes:

­ Regular contact with the client.

­ Coordinating the planning and execution of the statistics related tasks as per the contract.

­ You will work with the project team to establish a clear project scope and timeline.

­ Working with the study data manager to ensure project deliverables are achieved and in compliance with regulatory requirements.

­ You will ensure high quality, on time statistical deliverables.

­ Managing the financial aspects for the statistical portion of the project.

­ Working closely with the programmers to coordinate deliverables.

2. Preparation and review of statistical analysis plans in accordance with the study protocol for more complicated or unconventional clinical trials.

3. Writes and reviews statistical method section for protocols independently.

4. Estimates sample sizes for clinical trials.

5. Advises clients on statistical design issues.

6. Performs QC of tables, listings, graphs, and derived datasets, particularly those of a more complicated nature or those used for efficacy analyses.

7. Reviews CRFs and data management plans.

8. Can independently develop computer programs to generate tables, listings, and graphs using SAS as outlined by the statistical analysis plan.

9. Performs quality review of statistics deliverables to clients.

10. Works with programmers to ensure statistical analyses are accurate and carried out correctly.

11. Reviews clinical study reports.

12. May assist in business development activities including study pricing and new business acquisition.

13. Adheres to all study/project timelines.

14. Documents work so other statisticians and programmers can check or modify work.

15. Suggests process improvements for work procedures.

16. Assists with the training and mentoring of new employees as needed.

17. Adheres to all policies, procedures, SOPs, and training plans.

18. Leads and/or contributes to internal process improvement initiatives.

19. Files study documents into Biometrics internal files.

21. Other duties as assigned.

Candidate Requirements:

We seek a statistician with a minimum of 5 years of experience within the pharmaceutical industry and experience programming with SAS for statistical analysis.

We seek a professional with a Master's Degree or PhD in statistics, biostatistics, or a closely related field.

Candidates should have a sound understanding of Good Statistical Practices and various regulatory requirements FDA, EU, ICH), knowledge of clinical trial design, FDA regulations, and quality standards.

Send Resume and Cover Letter to:

Tracy Wolfe

twolfe@zingaro.com

Phone: 512 327-7277