The Director, Clinical Biostatistics leads the activities of biostatisticians and participates in the design, analysis, and reporting of clinical data from studies to support the development, validation, and utility of cancer tests designed to support cancer patients and improve outcomes. The Director, Clinical Biostatistics is able to influence decisions within and outside the company relating to design and analysis of clinical studies and interpretation of data; effectively negotiates schedules and critical priorities with senior level management, colleagues from other functions, and external collaborators; contributes to the resolution of high impact issues within and outside of Exact Sciences, most frequently in the role of content expert; and may represent Exact Sciences as a prime internal and external contact on major operational issues.
Essential Duties and Responsibilities
- Leads activities within the Biostatistics organization in the development, analysis, and reporting of clinical data to support regulatory approvals, reimbursement, and adoption of new cancer diagnostics.
- Directs the work of, and reviews the deliverables of, other Clinical Biostatistics staff.
- Provides technical leadership to the Biostatistics group in relevant statistical methods.
- Performs statistical activities; including protocol development, development of analysis plans, data analysis, and preparation of final study reports.
- Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles, and may impact future concepts, products, or technologies.
- Creates networks with external clinical and statistical collaborators and influences decisions to ensure quality of study designs and analyses, appropriateness of inferences and conclusions, and alignment with company strategic interests.
- Critically reviews study protocols, statistical analysis plans, abstracts, posters, and publications.
- Works on extremely complex problems while exercising independent judgment in selecting and adapting, as necessary, methods appropriate for the specific objective.
- Contributes to clinical development plans and integrated strategic plans.
- Conducts independent research in statistical methods to support goals.
- Identify functional process needs, drives standardization, and defines and implements best practices for Clinical Biostatistics.
- Assesses and recommends functional headcount requirements, associated recruiting and hiring decisions, and onboarding of newly hired staff.
- Supervise staff including but not limited to organize and prioritize work, write/conduct performance reviews, train/develop, goal setting, professional development, mentor, and manage work performance.
- Communicate goals clearly to employees to ensure understanding and success in achieving them.
- Motivate and inspire employees to do their best work through coaching.
- Maintain morale and support employee engagement initiatives.
- 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 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 locations.
- Ability to travel 15% of working time away from work location, may include overnight/weekend travel.
- Master’s degree in biostatistics, statistics, or a comparable field.
- 10+ years of related work experience in academia or industry.
- 8+ years of direct leadership experience.
- Demonstrated knowledge of theoretical and applied statistics.
- Demonstrated proficiency in oncology trials, cancer diagnostics, and/or epidemiology studies.
- Demonstrated knowledge of R or SAS for statistical analysis.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
- PhD. in biostatistics, statistics, or a comparable field.
- In-depth knowledge of survival analysis and epidemiological methods.