Principal Statistician

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life.

• Is responsible for the development of statistical plans which require effective communication with project manager/CRA to understand the objective of a study. Also, must have the ability to independently research and provide appropriate statistical input for the study design.
• Is able to program in SAS efficiently and able to troubleshoot data issues effectively.
• Is able to conduct review of project documentation, program algorithms and analysis outputs to ensure accuracy.
• Reviews statistical plans, protocols, submissions, and any other publication for accuracy.
• Is closely involved with projects to ensure the time line deadlines are achieved.
• Is able to help in the preparation and review of journal articles, posters, or other publications.

• Responsible for completing direct reports performance reviews and career path discussion, if applicable.
• Participates in the interviewing, hiring and training of new statisticians.
• Mentors new employees.
• Organizes and participates in inter-department projects/activities/forums.
• For each study, ensures that policy/procedures are followed to guarantee compliance with all required regulations.
• Is able to adapt to changing priorities.
• Is able to take initiative on projects to ensure they are completed accurately and on time.
• Motivate and encourages peers and co-workers.

Education:

• MS (PhD preferred) Statistics, Biostatistics or related technical area of life-science, mathematics, etc. (with a significant amount of coursework in statistical methods/analyses) + 5 years of experience.
• A technical background is critical to performance and understanding the basic science that supports and links the compliance to regulations.

Background:

• Demonstration of strategic planning, resource planning, and project management.
• Good organization, communication, interpersonal, and team skills.
• Knowledge of AM products desirable.
• Excellent written and oral communication skills.
• Computer fluency in processing, flow diagrams, and spreadsheets.
• Good working knowledge of personal computer software programs in Windows environment.

Accountability / Scope:

• Successful and timely completion of the statistical analyses and proper record storage for clinical studies and submissions directly impacts the ability to meet product market entry dates.
• Responsible to interact on the behalf of a project with FDA reviewers or compliance personnel.
• Responsible for mentoring new employees.
• Ensure compliance requirements are incorporated into area activities involving statistics.
• Confirm that quality standards for accuracy and completeness are met.