Statistician

Pharmaceutical Company located in the North Suburbs of Chicago has a need for a Statistician with Clinical Trial experience. This position is slated to start anytime in September. Open to candidates with mid to upper level experience. This is an excellent opportunity to work with a leading International Company on the move up. This is a one year contract with extension opportunities based on performance.

OBJECTIVE: 



The purpose of this position is to provide program-level statistical expertise by:

·         Designing, analyzing and interpreting clinical studies and programs

·         Standardizing study design, analysis methodology and presentations to maximize global data integratability.

·         Leveraging external vendors providing statistical services to achieve quality, timely, cost-effective study deliverables.

 

ACCOUNTABILITIES: 



·         Represent the statistics function in support of clinical studies led from either the US or EU.

·         Provide statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions.

·         Provide accurate, statistically appropriate outputs included in protocols, statistical analysis plans, study reports and regulatory submission documents.

·         Implement project level database (including derived database), analysis and reporting standards. 

·         Plan and direct study-level analysis and reporting activities including work of other programmers.

·         Identify study-level vendor requirements and participate in the evaluation/selection of BDM vendors. Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.

·         Anticipate and communicate resource and quality issues that may impact deliverables or timelines.  Propose and implement solutions. Escalate issues to management as appropriate.

·         Contribute to increasing efficiency of the Statistics function through development of standard analysis methodology, data presentations and sharing of best practices. Support implementation of such standards and process improvements.

·         Comply with all applicable regulatory requirements, standards and procedures.

·         Perform other duties as assigned.

 

 

EDUCATION, EXPERIENCE AND SKILLS: 



·         PhD in statistics or biostatistics with minimum of 2 years of relevant experience or MS in statistics or biostatistics with minimum of 5 years of relevant experience.

·         Knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics, and data presentation practices.

·         Knowledge of the pharmaceutical industry including understanding of clinical drug development process and documents.

·         Knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.

·         Good knowledge of statistical programming languages (including SAS), software, techniques, and processes. Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft OfficeÒ products).

·         General project management skills.

·         Good oral and written communications skills

For immediate consideration, please contact:
Chip Holway
847-374-8250 x239