STATISTICIAN

A leading pharmaceutical company located in the northern suburbs of Chicago is looking for a Statistician to join their team!
1 YR + contract length

Responsibilities: Provide statistical expertise to design clinical trials, define and execute analyses and interpret statistical results. Define analysis endpoints, statistical methodology and sample size for clinical trials. Efficiently provide accurate, statistically appropriate outputs included in protocols, statistical analysis plans, study reports and regulatory submission documents. Plan and direct study-level statistics activities including work of other statisticians, programmers and contract research organizations (CROs). Confirm accuracy of statistical outputs produced by CROs. Provide timely, high-quality review of clinical trial documents (e.g., protocols, case report forms, study reports) and outsourcing documents (e.g., proposals, task orders and change orders). Provide statistical input to drug development and submission plans. Contribute to definition of strategies to address statistical questions from regulatory authorities. Contribute to definition of project level database, analysis and reporting standards. Comply with all applicable regulatory requirements and company's standards and procedures.

Requirements: PhD in Statistics or Biostatistics with 4 plus years of experience supporting clinical trials in the pharmaceutical industry. Advanced knowledge of statistical methods routinely used in clinical trials. Advanced knowledge of processes for planning, conduct, data processing, analysis and reporting of cllinical trials. Proficient use of statistical analysis software (SAS). Understanding of drug development processes. Knowledge of FDA and ICH regulations applicable to the design, analysis and reporting of clinical trials.

Keywords: Illinois, IL, Medfocus, Statistician, Biostatistician, Pharma*, Clin*, Contract
REQUIREMENTS
Requirements: PhD in Statistics or Biostatistics with 4 plus years of experience supporting clinical trials in the pharmaceutical industry. Advanced knowledge of statistical methods routinely used in clinical trials. Advanced knowledge of processes for planning, conduct, data processing, analysis and reporting of cllinical trials. Proficient use of statistical analysis software (SAS). Understanding of drug development processes. Knowledge of FDA and ICH regulations applicable to the design, analysis and reporting of clinical trials.

Keywords: Illinois, IL, Medfocus, Statistician, Biostatistician, Pharma*, Clin*, Contract