Exact Sciences Corporation

Lead Clinical Biostatistician

Job Locations US-CA-Redwood City
Req No.
2020-5442
Category
Clinical Lab Operations
Type
Regular Full-Time

Summary of Major Responsibilities

Genomic Health and Exact Sciences have come together to become the world's leader in Cancer Diagnostics. The vision and expertise of our employees and strategic collaborators enable us to provide life-changing, smarter answers when they’re needed the most. We are united in our commitment to pursue earlier cancer detection, treatment guidance, and monitoring.

 

A successful candidate for the Lead Clinical Biostatistician will hold strong statistical and computational skills to lead in the development, validation, and support of post-marketing activities for genomic assays. The Lead Clinical Biostatistician will directly partner with internal and external thought leaders in the design, analysis, reporting, and publication of clinical trials and observational studies in oncology. This position requires in-depth understanding of survival analysis and epidemiological methods.

Essential Duties and Responsibilities

  • Perform statistical activities in support of development and medical affairs studies, including development of study design and protocol, development of statistical analysis plans, data analysis, algorithm development, preparation of final study reports, abstracts, posters, and manuscripts.
  • Represent the statistics function on project teams for clinical development programs, providing strategic input and contributing significantly to the design of clinical studies and the clinical development plan.
  • Work on significant and unique issues. 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.
  • Direct, with input from others, the activities within the Biostatistics organization for the development of prognostic and/or predictive markers.
  • Interact with external clinical and statistical collaborators.
  • Motivate and inspire employees to do their best work through coaching and mentoring.
  • Maintain morale and support employee engagement initiatives.
  • Knowledge of theoretical and applied statistics.
  • Strong statistical programming and analysis skills in SAS.
  • Excellent oral, written, and presentation skills.
  • Professional manner with the ability to communicate 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 independently lead complex research or development projects requiring an understanding of scientific principles and concepts, as well as relevant developments in the field (including peer-reviewed internal or external presentations or publications) that demonstrate expertise in the field.
  • Ability to interact with and exert significant influence of 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.
  • 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 work designated schedule.
  • 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 60% of a typical working day.
  • Ability to spend 60% of a typical working day concentrating and or analyzing data.
  • 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 and 12 years of relevant work experience in industry, academia or a research institute; or Master’s degree in Biostatistics or Statistics and 15 years of relevant work experience in industry, academia, or a research institute in lieu of Ph.D.
  • Demonstrated success in developing and validating a prognostic or predictive genomic marker; or demonstrated success in leading the statistical portion of a clinical development program.
  • Knowledge of survival analysis and epidemiological methods.
  • Basic computer skills to include Internet navigation, Email usage, and word processing.
  • Proficient in Microsoft Office.
  • Professional knowledge in publishing results of clinical, epidemiologic or genomic studies.
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

  • Professional knowledge using R.
  • Professional knowledge analyzing genomic marker data.
  • Professional knowledge working in oncology and clinical diagnostics.
  • Professional knowledge working in the regulated industry (FDA or EU).

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.

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