Statistician

73,000-86,000 salary

This can be remote but need to be on the East Coast.

Looking for candidates who have had training or some experience in any or all of the following areas; statistics, statistical process control, continued process verification, process validation.

We are seeking a Statistician to join our Data Science and Statistics team. This position directly supports all our CPV related statistical needs, and provides guidance in the utilization of appropriate statistical methodology to scientists and management in the Global Manufacturing Operations.

About the Role

Responsibilities:

• Provide sound statistical input to support our CPV program, by applying appropriate methodology to solve problems.
• Prepare statistical analysis plans.
• Analyze historical data to ensure the commercial manufacturing operations remain in state of control, through appropriate use of statistical process control and capability analysis.
• Support the root cause analysis activities and explain the findings to non-statisticians.
• Follow the quality requirements to ensure all data and analysis remain validated.
• Prepare the statistical section of technical reports and presentations.
• Manage one's projects effectively, and meet deadlines with high quality of standards.
• Meet project timelines.
• Outside of the CPV program, perform any other analysis needed to support the Global Manufacturing Operations teams as well as other CMC teams.

Requirements:

• A degree in Statistics/Biostatistics, Bioengineering, Chemical Engineering, or a related field, with at least 1 year of relevant experience.
• Sound knowledge of theoretical and applied statistics is required, with an emphasis on statistical process control.
• The candidate should have hands-on experience with using and scripting statistical software packages including JMP and R.
• 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.