Clinical Statistician II

COMPANY INFO:

 

NOW HIRING!! Are you looking to expand your career and enhance your professional skills? MedFocus is now seeking a Clinical Statistician II - C

 

Our client is developing leading positions in seven major therapeutic areas.

A Major Pharmaceutical Company is looking for a Clinical Statistician II - C in Northern Suburb of Chicago, Illinois.

 

Data Analysis:

- Write SAS code for common statistical analyses.

- Understands and correctly uses validated SAS macros in the data analysis programs.

- Conducts thorough and detailed reviews of project documentation, program algorithms and analysis outputs.

- Interprets the analysis output clearly and effectively.

- Identifies data analysis related issues and resolves promptly

 

Study Preparation:

- Meets with CRA, RD, Instrumentation scientists, department data collection programmers, and data entry to find the best way of capturing the data.

- Reviews the study protocol; understands the protocol; and ensures that the correct data is being collected to achieve the objective(s) of the protocol

 

Developing Statistical Plan:

- Effectively communicates with project manager/CRA to understand to objectives of the study.

- Follows the appropriate operating procedure required for developing the statistical plan.

- Demonstrates the ability to research and provide appropriate statistical input to the study design.

- Using templates or examples, writes accurate statistical plans that are clear and understandable to the reviewers.

- Explains the rationale of the statistical methods to the project team.

- Attends and participates in the team meetings.

 

Post Analysis Activities:

- Participates in the creation of the verification plan and line listings.

- Prepares and reviews statistical sections contained in submissions and other publications.

- Prepares statistical summaries in a timely manner for team and management review

 

Minimum Education:

- B.S. Statistics (or related field) + 1 year experience or MS/PhD in Statistics( or related field)

 

Minimum Experience:

- SAS programming, statistical writing, experience in data analysis.

- Knowledge of regulations and standards affecting IVDs and Biologics.


KEYWORDS:

Clinical, Clinical Trial Manager, Clinical Site Manager, Study Manager, Protocol, Clinical Research Associate, CRA, Biostatistician, Statistician, Data Manager, Coordinator, Statistical Programmer, SAS Programmer, CDISC, Biometrics, Statistics, Medical Writing, Regulatory, Scientist, Clinical Scientist, Dug Safety, Drug Safety Associate, Contracts Manager, Document Specialist, Clinical Support Specialist, Biostatistics, Monitor, Regional CRA, CRF, Case Report Form, Trial Master File, NDA, IND, Protocol, Investigator Brochure, ICH GCP Guidelines, Pharmaceutical Company, Biotech, Biotechnology, Medical Device, CRO, Clinical Research Organization, Outsourcing, 1572, Tables, Listings and Graphs, TLGs, Director, Regulatory Affairs, Associate, Clinical Trial Associate, CTA, Oracle Clinical, ClinTrial, Physician, PhD, MD, Medical Monitor

 

 

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.

 

 

PUT YOUR INTEREST INTO ACTION AND CLICK APPLY NOW!!!!