Statistician II/III

An American Company is seeking a Statistician II/III in Gaithersburg, MD.

Role Description

We are seeking a Statistician II/III to join our Data Science and Statistics team. This position directly supports all our nonclinical groups, and provides guidance in the utilization of appropriate statistical methodology to scientists and management.

• Provide sound strategic, scientific, and statistical input to support our nonclinical research and development projects, through design of experiments and by using appropriate statistical methodology and sample size.

• Prepare statistical analysis plans; analyze experimental and historical data.

• Create design of experiments and perform various types of statistical analyses to develop predictive models and optimize conditions for processes, methods, and drug product/drug substance storage.

• Perform stability analysis to identify degradation rates and expiration dates.

• Prepare the statistical section of technical reports and presentations.

• Engage in discussions and research to ensure the central place of applied statistics in research, development, quality, and validation projects.

• Manage one's projects effectively, and meet deadlines with high quality of standards

• Explain statistical designs and concepts to non-statisticians

• Meet company milestones

Skills & Requirements

• A degree in Statistics/Biostatistics, Bioengineering, Chemical Engineering, or a related field, with at least 5 year of relevant experience is preferred.

• Sound knowledge of theoretical and applied statistics is required, with an emphasis on experimental design in biotechnology, power calculations, survival analysis, etc.

• The candidate should have hands-on experience with using and scripting statistical software packages including JMP, SAS, and R.

• Familiarity with ICH guidelines

• Experience in the drug development field is preferred.

• Must be an effective team player, able to thrive in a fast-paced team environment, and also work independently on projects.

• Excellent interpersonal, oral, and written communication skills.

• Leadership ability to influence team members and communicate statistical concepts across functions.