Senior Statistician

Location: Chicago, IL

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:
Power and sample size calculations. Advises clients on statistical design issues.
Writes and reviews statistical methods section for protocols independently.
Estimates sample sizes for clinical trials. Works directly with client to determine best parameters for design.
Preparation and review of statistical analysis plans in accordance with the study protocol for more complicated or unconventional clinical trials.
Reviews CRFs and data management plans.
Can independently develop computer programs to generate tables, listings, and graphs using SAS as outlined by the statistical analysis plan.
Performs QC of tables, listings, graphs, and derived datasets, particularly those of a more complicated nature or those used for efficacy analyses.
Reviews Clinical Study Reports.
Serves as the lead statistician on project teams for the execution of clinical trials.
This includes:
-Technical guidance for project
-Regular contact with the client
-Coordinating the planning and execution of the statistics related tasks as per the contract
-Working with the programmers to ensure statistical analyses are accurate and carried out correctly
-Working with the project team to establish clear project scope and timelines
-Coordinating with the study data manager to ensure project deliverables are achieved complying with regulatory requirements
-Ensuring 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
Performs quality review of statistics deliverables to clients.
Writes statistical reports.
Provides technical leadership to the department where standard methods are not appropriate.
Interacts with regulatory authorities (e.g., FDA, EMEA) regarding statistical issues related to clinical trials.
Gives presentations on technical issues to other employees.
May assist in business development activities including study pricing, new business acquisition, and representation at bid defense meetings.
Represents Company statistics to external groups.
Assists with audits that involve the statistics group.
Adheres to all study/project timelines.
Documents work so other statisticians and programmers may check or modify work.
Assists with the training and mentoring of new and more junior employees as needed.
Adheres to all Company policies, procedures, SOPs, and training plans.

Candidate Profile and Requirements:
1.We seek a professional with a Master's Degree or PhD in statistics, biostatistics, or a closely related field.
2. We seek a statistician with 5-8 years of experience within the pharmaceutical industry and experience programming with SAS for statistical analysis.
3.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.

Compensation:
A compensation package will be designed to attract outstanding talent and will include a base salary plus incentive bonus.

Send Resume and Cover Letter to:
Tracy Wolfe
twolfe@zingaro.com
Phone: 512 327-7277

21936 Briarcliff Drive · Briarcliff, Texas 78669-2012
Phone: 512-327-7275 · Fax: 512-327-1774
E-mail: search@pprecruiters.com · Website: www.pprecruiters.com
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