Exact Sciences Corporation

Principal Biostatistician

Job Locations US-CA-Redwood City
Req No.
2020-6238
Category
Medical Affairs
Type
Regular Full-Time

Summary of Major Responsibilities

We are seeking an exceptional Principal Biostatistician with 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. This role will directly collaborate with internal and external thought leaders in the design, analysis, and reporting of product development and clinical studies in oncology. 

Essential Duties and Responsibilities

  • Perform statistical activities in collaboration across the organization. Support may include, but is not limited to, clinical studies, algorithm development, quality monitoring, process improvement, and automation. Activities include protocol and analysis plan development, data analysis, and preparation of final study reports, abstracts, posters, and manuscripts, with minimal supervision.  
  • Represent the statistics function on project teams for R&D programs, providing strategic input and contributing significantly to the design of clinical studies as needed.
  • Work on extremely complex problems. Exercises independent judgment in selecting and adapting, as necessary, methods appropriate for the specific objective. 
  • Strategic leader within the organization, who uses professional concepts and principles to achieve objectives in creative and effective ways.
  • Coordinate, with input from others, the activities within the Biostatistics organization on technical projects; including the development of prognostic and/or predictive markers.
  • Interact with external clinical and statistical collaborators.
  • 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.
  • Able to work in a multi-disciplinary team; including scientists, pathologists, physicians, clinical affairs, regulatory affairs, 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 80% 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

  • Master’s degree in Biostatistics or Statistics.
  • 10+ years of relevant work experience in industry or academia.
  • 5+ years of experience designing and analyzing time to event data from clinical trials or observational studies; and/or significant experience designing/performing DOE studies for analytical methods development and validation.
  • 5+ years of experience in publishing the results of clinical, epidemiologic, or genomic studies.
  • Professional working knowledge of theoretical and applied statistics.
  • Strong statistical programming and analysis skills in SAS or R.
  • 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

  • Ph.D. in Biostatistics or Statistics with 8+ years relevant work experience in industry.
  • Experience working in oncology.
  • Experience analyzing high dimensional data, preferably genomic data.
  • 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).

#LI-AL1

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.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed