Sr. Non-Clinical Biostatistician

Position Overview

The Senior Non-Clinical Biostatistician applies strong statistical and computational skills to participate in the development, validation, and support of genomic biomarker assays. This role directly partners with cross-functional teams in the design, analysis, reporting, and internal publication of reports pertaining to analytical validation and process monitoring. This position requires in-depth understanding of evidence generation in molecular diagnostics, ranging from development, verification, and analytic validation to clinical validation and process control. The ideal candidate will possess strong analytical and communication skills.

Essential Duties Include, but are not limited to, the following:

• Perform statistical activities in support of development of experimental and study design and protocol, data analysis, methods of process surveillance, preparation of study reports, serve as subject matter expert in service of regulatory submissions, and liaise with cross-functional departments.
• Exercise independent judgment in selecting and adapting methods appropriate for the specific objective.
• Use professional concepts and principles to achieve objectives in creative and effective ways.
• Partner with statistical collaborators.
• Apply knowledge of theoretical and applied statistics.
• Apply strong statistical programming and analysis skills in industry standard analysis software, e.g., SAS, R, Python.
• Apply excellent oral, written, and presentation skills.
• Communicate professionally and effectively throughout all levels of the organization.
• Ability to work effectively in a multi-disciplinary team including scientists, pathologists, oncologists, and representatives from commercial, legal, and business development functions.
• Ability to prioritize and drive results with a strong emphasis on quality.
• Ability to integrate and apply feedback in a professional manner.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to travel between Abbott Cancer Diagnostics locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.
• Apply strong verbal, writing, and presentation skills.
• Ability to communicate professionally and effectively with other functions.

Minimum Qualifications

• Master’s degree in Biostatistics or field as outlined in the essential duties.
• 6+ years of relevant experience as outlined in the essential duties.
• Professional working knowledge of theoretical and applied statistics.
• Strong statistical programming skills (SAS, R, or Python).
• Demonstrated proficiency in Microsoft Office, including Word, Excel, PowerPoint, (etc.)
• Strong verbal, written, and graphical communication/presentation skills.
• Demonstrated ability to regularly seek and integrate feedback from team members and managers in a professional manner.
• Demonstrated ability to work independently, prioritizing and producing high quality results.
• Demonstrated ability to collaborate effectively as part of a cross-functional team.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• PhD in Biostatistics or 9+ years of relevant experience as outlined in the essential duties.
• Demonstrated statistical experience in molecular diagnostic, drug, or medical device development.
• Experience working in oncology.
• Experience in developing products for approval by regulatory authorities such as FDA.