Hologic Clinical Scientist 2 (Biostatistician) in Marlborough, Massachusetts
Working to support the development of innovative and transformative technologies, the Clinical Scientist will develop and execute clinical studies aimed at demonstrating the safety and efficacy of Hologic products across the continuum of patient care. Working alongside a cross-functional cadre of stakeholders spanning R&D, Regulatory Affairs and Marketing, the Clinical Scientist will be a key contributor in the design and interpretation of clinical studies and medical literature.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Strategically identify and define relevant clinical questions and needs along a cross-functional group of internal stakeholders.
Work alongside an interdisciplinary team of applied scientists in identifying, designing, initiating, and managing necessary internal and external clinical trials and studies to drive evidence generation across company product lines.
Build statistical analyses plans and frameworks to support internal design validation and verification activities, regulatory submissions, pilot level studies aimed at powering independent pivotal studies, outcomes research, as well as participating in external CRO and Academic consulting relationships.
Contribute to activities in support of regulatory clearance, clinical acceptance and payer and society guidelines to drive product adoption.
Develop and cultivate Hologic’s scientific partnerships with U.S. and International external experts, academic institutions, professional societies, cooperative groups and their foundations, large multi-center research organizations and other relevant external parties.
Drive the exploration of future spaces for existing and upcoming products, direct evidentiary gap analysis and needs assessment, and strategically plan against market expansion targets.
Participate in systematic literature reviews aimed at collecting tier I-III evidence in support of company products.
Provide scientific guidance in the critical appraisal of literature supporting competitor products to maintain competitive attractiveness.
Participate in competitive intelligence activities aimed at remaining current with ongoing trials and studies evaluating company and/or competitor products.
Serve as an acknowledged expert on company’s products and related competitive products in all topics relevant to external customers, specifically: clinical, scientific, technical and health outcomes and economics research.
Clinical or research experience in breast cancer screening, diagnostics and treatment domains
Knowledge and understanding of medical and clinical terminology, clinical workflow, and biostatistics analysis and software (e.g.; STATA, SAS, and/or R)
Understanding of regulatory issues in the medical device space and GCP
Excellent oral and written communications skills as well as presentation skills and the ability to effectively communicate Hologic’s position to various stakeholders to achieve operational alignment
Experience in developing and managing academic-industrial partnerships
Proven strong interpersonal skills and ability to succeed in a matrixed environment
Attention to detail and ability to meet deadlines
Strong organizational skills with the ability to multi-task and adjust to changing priorities
Demonstrated ability to think strategically, set and manage priorities, manage multiple projects and allocate and reallocate resources and effort as required
Collaborative mindset to achieve common goals
Ability to travel up to 25% travel; with 2 international trips per year
- Ph.D. or Master’s degree in quantitative sciences or related disciplines (e.g., Biostatistics, Public Health, Biomedical Engineering, Computer Science, etc.)
PhD with 0-2 years of related experience or MS / MPH with 2 – 5 years of related experience
Experience in the healthcare industry strongly desired
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.