Principal Clinical Biostatistician

Help us change lives

At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

Position Overview

The Principal Biostatistician applies strong statistical and computational skills to participate in the discovery, development, validation, and post-marketing support of genomic biomarker assays that help cancer patients and their physicians make better treatment decisions. As a member of the Clinical Biostatistics team, this role directly collaborates with internal and external thought leaders in the design, analysis, and reporting of product development and clinical studies in oncology.  Additionally, the Principal Biostatistician applies complex statistical methodology contributing to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions and publications.  The ideal candidate will possess strong analytical and communication skills.

Essential Duties

• Independently and effectively contribute as a product owner across multiple biostatistics functions, providing strategic input and contributing significantly to objectives in creative ways.
• Design and advise the design of clinical validity, clinical utility, health economics, and clinical experience studies by:
  • Evaluating evidentiary requirements
  • Contributing to proposals, FDA pre-submissions, and study protocols (selecting endpoints, power and sample size calculations, and analysis plans)
  • Reviewing case report forms and data transfer requirements
  • Authoring and reviewing statistical analysis plans
• Apply complex statistical methodology and programming to:
  • Monitor clinical data quality
  • Develop evidence for clinical predictive models in clinical studies and trials
  • Conduct simulation studies
• Communicate statistical results in tables, figures, and listings; statistical analysis reports; clinical study reports; abstracts; manuscripts; regulatory submissions; presentations; and marketing collateral.
• Evaluate investigator sponsored study designs and analysis plans, evidence developed for external molecular tests, and applicability of novel statistical techniques.
• Ability to be highly effective and pro-active in a fast-paced and rapid growth environment.
• Apply strong verbal, writing, and presentation skills.
• Ability to communicate professionally and effectively with other functions.
• 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 and means to travel between local Exact Sciences locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

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

• 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.