Exact Sciences is seeking an exceptional individual with strong statistical and computational skills to participate in the post-marketing support of oncology screening and diagnostic products. The individual will directly collaborate with internal and external thought leaders in the design, analysis, reporting, and publication of clinical studies and real-world evidence generation. A strong candidate will have extensive experience analyzing, mining, and developing visualizations for high dimensional data, preferably genomic data. This role may lead a small team of individual contributors.
Essential Duties and Responsibilities
Perform statistical activities in collaboration with departments across the organization on post-marketing clinical research, medical affairs activities, and real-world evidence generation. Support includes protocol and analysis plan development; data analysis; data visualizations; and preparation of study reports, abstracts, posters, and manuscripts. These activities will be undertaken with minimal supervision.
Represent the statistics function on project teams for post-marketing programs, providing strategic input, and contributing to the design of studies.
Provide statistical input and/or review of marketing, sales, medical education, and training materials pertaining to clinical study data and product claims.
Analyze high dimensional data.
Analyze time to event data from clinical trials or observational studies.
Support analysis of clinical laboratory experience data and associated publications.
Work on extremely complex problems. Exercise independent judgment in selecting and adapting, as necessary, methods appropriate for the specific objective.
Lead strategically within the organization, using professional concepts and principles to achieve objectives in creative and effective ways.
Coordinate activities and technical projects across the statistics function.
Interact with external clinical and statistical collaborators.
Stay abreast of the latest methodological developments in the real-world evidence generation and apply to clinical study design, analysis, and strategic input.
Provide guidance to and/or oversight of more junior personnel, as needed, but primary role is an individual contributor.
Professional manner with the ability to communicate effectively throughout all levels of the organization.
Ability to work in a multi-disciplinary team including scientists, pathologists, oncologists, engineers, and quality assurance personnel.
Ability to interact with internal and external collaborators on study design, analysis methods, and interpretation of study results, in consultation with senior management and the program team.
Ability to prioritize and drive to results with a strong emphasis on quality.
Ability to integrate and apply feedback in a professional manner.
Excellent oral, written, and presentation skills.
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.
Regular and reliable attendance.
Ability to lift up to 10 pounds for approximately 5% of a typical working day.
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 Redwood City locations.
Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
Qualifications
Minimum Qualifications
Ph.D. in Biostatistics or Statistics; or Master's Degree in Biostatistics or Statistics and 2 years of relevant experience in lieu of Ph.D.
8+ years of relevant work experience in industry or academia; including strong statistical programming and analysis skills in SAS or R and experience in publishing the results of clinical, epidemiologic, or genomic studies.
Professional working knowledge of theoretical and applied statistics.
Basic computer skills to include Internet navigation, Email usage, and word processing.
Proficient in Microsoft Office.
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
Experience working in oncology.
Professional working knowledge with genomic assays and/or in vitro diagnostics; including algorithm development.
Experience developing/applying high performance computing and machine learning methodologies to problems involving structured and unstructured biological data.
Experience working in the regulated industry (FDA or EU).
Experience as a direct leader of individual contributors.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.
