• Manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes • Leads RBM strategy meetings and develops study-specific site monitoring plan, aligned with study risk assessment • Ensures monitoring strategies are configured in technology capabilities • Manages Site Monitoring assignments in client's systems • Provides Site Monitoring training and supports the creation and delivery of site monitoring materials • Serves as primary reviewer of site monitoring visit reports • Reviews systems and dashboards to assess site monitoring compliance • Supports site monitoring needs during study conduct • Provides site management back-up as needed while Site Monitors are conducting site monitoring visits • Triggers and manages or conducts Monitoring Oversight Visits • Partners with RBQM Operations team to address unresolving centralized monitoring findings with sites • Performs periodic assessment of site monitoring / RBM compliance KPIs and KQIs

• Design and conduct clinical studies that evaluate the safety and efficacy of innovative treatments. • Contribute to the development and creation of clinical trial protocols following high scientific and clinical standards and applicable regulations. • Contribute to the identification, formulation and implementation of amendments to the clinical protocol, in close collaboration with clinical lead. • Contribute to the creation of study-level documents, including preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. • Contribute to the review and writing of clinical trial documents for CTR activities, and publications (as applicable) • Support pharmacovigilance activities (e.g. contributing to creation and review of aggregate reports, patient narratives and attendance of pharmacovigilance monitoring meetings) • Support regulatory activities (preparation of meetings with regulatory agencies). • Produce training materials, share best practices and provide training to the broader clinical trial teams. • Support preparation and (if applicable) participate in study level meetings (i.e. - Investigator Meetings, Data Monitoring meetings, and others). • Support and guide the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/ sites). • Include support for Case Report Form (CRF) development, and implementation of data capture tools. • Deep expertise to perform in depth and high-quality clinical data review, to identify clinical data insights through ongoing patient level review and trends analysis to support Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle. • Work to improve the quality of reviews and insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review. • Provide insights to and facilitate data review process improvements by identification of redundant reports, implementation of innovative data analysis processes and tools, and their continuous improvement.

Develop and execute clinical strategies for oncology diagnostic products, manage clinical validation studies, and collaborate cross-functionally to support regulatory submissions and product development, ensuring scientific rigor and alignment with...

Role Description The Senior Biostatistician is responsible for independently providing statistical expertise and managing the activities for personalized medicine companion diagnostic device analytical and clinical studies to ensure valid and efficient study designs that allow clearly interpretable results and timely delivery of data analyses, study reports and regulatory documents with high quality. The incumbent independently mentors junior staff; builds and maintains strong collaboration with other teams across the organization to develop study plans, study protocol, and decision framework as well as provide responses to statistical issues arising in regulatory or external partners. The function contributes to the long-term growth strategy of the Scientific Operations team by participating in process improvement initiatives and contributing to the development of statistical methodologies applicable to companion diagnostic validation. Key Responsibilities - Lead independently the design and data analysis of analytical and clinical validation studies on novel next generation sequencing-based companion diagnostic devices for oncology. - Represent the team within broad cross-functional projects and oversee multiple project teams. - Independently mentor junior members on design and project deliverables. - Provide key contributions to the analytical and clinical studies in the program, including but not limited to protocol development, statistical analysis plans, and data reporting. - Contribute to the planning and delivery of key analytical or clinical components of regulatory submissions, including but not limited to Q-subs, PMA, and sPMA. - Represent Biostatistics in key regulatory meetings. - Develop innovative and creative statistical and technical solutions to complex problems. - Maintain statistics quality standards throughout the study process and statistical accuracy in all documents pertaining to the study. - Ensure statistical work is completed in accordance with established timeframes. - Track biostatistics activity deliverables. - Collaborate with laboratory scientists, technologists and the Regulatory team on study design, planning, data preparation, programming, analysis and presentation of results. - Draft study protocols and issue final reports on these studies. - Maintain availability to the wider FMI business for statistical interpretation and analysis. - Solicit feedback and communicate study results within FMI and to external stakeholders. - Other duties as assigned. - Comply with FMI's attendance policies. Qualifications - Master’s Degree in Statistics (or Biostatistics) and 7+ years of experience as a statistician in academia, biopharmaceutical, or diagnostics industry, academia, or FDA; OR, - PhD in Statistics (or Biostatistics) and 5+ year(s) of experience as a statistician in academia or in the biopharmaceutical or diagnostics industry, academia, or FDA. - Proficiency in statistical programming language R or SAS. Preferred Qualifications - Doctor of Philosophy in Biostatistics or Statistics. - 3+ years of experience as a statistician in academia or in the biopharmaceutical or diagnostics industry, or FDA. - Experience in time-to-event data analysis, cluster/longitudinal data analysis, clinical trials, random effect and measurement error models. - Experience in experimental study design and statistical methods in diagnostic medicine. - Extensive scientific understanding of cancer genetics and genomics. - Knowledge and experience with Next-Generation Sequencing (NGS). - Experience leading or managing a team of Biostatisticians. - Demonstrated leadership skills including proactive strategy setting, priority evaluations, conflict resolution, and effective partnerships. - Strong programming skills, technical proficiency and creativity. - Demonstrated history of independent thinking. - Demonstrated ability to meet project deadlines. - Demonstrated record of successful independent work and contributions to team projects. - Excellent communication, presentations and writing skills, and the ability to explain complex technical details in clear language. - High level of detail orientation with a focus on quality. - Ability to work well under pressure while maintaining a professional demeanor. - Understanding of HIPAA and the importance of patient data privacy. - Commitment to reflect FMI’s values: Integrity, Courage, and Passion. Salary and Benefits The expected salary range for this position based on the primary location of Remote is $145,000 - 179,000 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits. Company Description Foundation Medicine, Inc. (FMI) is a global, patient-focused precision medicine company delivering high-quality, transformative diagnostic solutions in cancer and other diseases. Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.