Biostatistics Manager

JOB DESCRIPTION

The Statistician conducts basic statistical analysis in support of clinical research studies as specified in statistical analysis plans, including statistical graphics; generates/verifies randomization codes; prepares statistical sections of protocols, including sample size calculations; prepares and annotates shell data displays; provides specifications for structure, content and algorithms for status and analysis datasets; performs and Supervises quality control of data displays that show inferential statistics.

QUALIFICATIONS FOR ESSENTIAL FUNCTIONS

1. Advanced skills in statistical and biostatistical analysis

2. Ability to communicate effectively in the English language in person, by phone and in writing

3. Designs, plans, and executes biostatistical components of clinical studies.

4. Uses statistical methodology to conduct studies and prepares statistical components of protocols.

5. Responsible for the statistical components of reports.

6. Develops statistical analysis plans and reporting specifications for clinical studies.

7. Reviews reports and underpins the results with statistical expertise.

8. Prepares and annotates shell data displays

9. Analyzes and interprets results from clinical studies using sound statistical methodology.

10. Contributes to the development of statistical analysis plans, including TFL shells.

11. Performs statistical analyses under the guidance of other statisticians or independently for simple clinical studies.

12. Assists with the review of TFLs, tabulation datasets, and derived datasets.

13. Advanced computer skills and practical knowledge of MS Word, Excel, PowerPoint, and project management software.

EDUCATION AND EXPERIENCE REQUIRED

1. Master's degree in Statistics.

2. A minimum of 3 years of experience as a statistician is required for the Senior Statistician position. A minimum of 1 year supervisory approval is required for the non-Senior

Statistician level.

1. Proficient in SAS and similar clinical data analysis software

WORK REQUIREMENTS

1. Corporate office environment unless home-based.

2. Some travel (5%) may be required with a potential of travel occurring over weekends.

3. Cross-functional interactions.

TRAINING

• Complete Training Requirements per current Training Requirements List.
• Manager will assign additional skills training, one-on-one, see-one / do one, or other Training as necessary to achieve qualifications and improve job performance.