Duties:

Ÿ  Protocol input, randomization schedule, and database activities.

Ÿ  Works with project team to decide on appropriate study design and statistical methodology for routine designs.

Ÿ  Responsible for protocol review.

Ÿ  Development of randomization schedule, sample size and power calculations.

Ÿ  Responsible for assuring that data for statistical analyses are accurate.

Ÿ  Implementation of protocol methodology and statistical analysis plans.

Ÿ  Responsible for the accuracy and timeliness of statistical input into reports or decisions.

Ÿ  Development of alternative analysis strategies when changes to planned analyses are needed.

Ÿ  Responsible for computer programs that are accurate, efficient and well documented.

Ÿ  Demonstrates understanding of statistical concepts and methodologies.

Ÿ  Development of the Statistical Methods section.

Ÿ  Responsible for accuracy of statistical tables and data listings, and accuracy of report text.

Ÿ  Identifies and corrects flaws in interpretation of results, inconsistency in presentation or inference.

Ÿ  Ensures accuracy of report text and consistency between summary tables in the body of reports and the corresponding statistical tables and listings.

Ÿ  Works collaboratively with peers to develop quality protocols, CRF, schema, and reports per agreed timelines.

Ÿ  Provides accurate and timely answers to routine questions from upper management.

Ÿ  Communicates an understanding of basic clinical principles for his/her project and acts in accordance with those principles.

Ÿ  Clearly communicate basic statistical concepts to other scientists and nonscientists. Informs supervisor or manager on important issues in a timely manner.

Ÿ  Effectively mentors non-statistical peers with regard to basic statistical methodology and departmental operations.

Skills/Requirements

• High degree of technical competence and communicative ability, both oral and written.
• Sr. level with multiple NDA submissions.
• Must be comfrotable with Clinical Trials Tables, Listings, and Figures as well as FDA requirements/regulations.
• Experience with Human Factors Testing and reporting, or development of questionaairres, statistical analysis plans, Case Report Forms. Can complete a data analysis report.
• Competent in experimental design, descriptive and inferential statistics, biometrics and computer systems.
• Pharmaceutical or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.
• Phd with industry experience preferred.
• MS degree with 3+ yrs exp or PhD with 1+ years exp.