Manage study operations, participant recruitment, and data collection for chronic disease research. Ensure regulatory compliance and support research execution, including IRB submissions and manuscript preparation, while utilizing data management tools...

Title: Biostatistician II Location: United States Department: Research Job Description: Description About the Job The Biostatistician II is responsible for providing statistical expertise and managing the activities for the development, clinical and analytical validation, and regulatory approval of FMI’s diagnostic devices including but not limited to companion diagnostic (CDx) devices. The incumbent ensures valid and efficient study designs that allow clearly interpretable results and timely delivery of data analyses, study reports and regulatory documents with high quality. This role builds and maintains strong collaborations with other departments across the organization to develop statistical methodologies and models, write study protocols, conduct statistical analyses, write study reports, present responses to statistical and study design questions arising from regulatory authorities or external partners (e.g., academic or Biopharma collaborators), represent FMI at meetings with regulatory agencies such as the Food and Drug Administration, contribute to scientific publications, and/or work with internal and external partners for the development, validation, and regulatory approval of FMI’s diagnostic assays in oncology and beyond. Key Responsibilities - Lead and execute the design and data analysis of analytical and clinical validation studies on novel next generation sequencing (NGS)-based diagnostic devices for oncology and beyond, including but not limited to protocol development, statistical analysis plans and reports, and data reporting. - Develop innovative and creative biostatistical and technical solutions to complex problems. - Represent the biostatistics team with guidance from senior team members within broad cross-functional projects. - Collaborate with cross-functional teams on study design, planning, strategy, data preparation, programming, analysis, and presentation of results. - Contribute to the planning and delivery of key analytical or clinical components of regulatory submissions and respond to review questions with guidance from senior team members. - Maintain biostatistics quality standards, biostatistics best practices, and accuracy across all study deliverables while ensuring analyses are completed in accordance with established timelines. - Maintain availability to the wider FMI business for biostatistical interpretation, analysis, and solutions. - Other duties as assigned. - Qualifications: Basic Qualifications: - Master’s Degree in Statistics or Biostatistics and 4+ years of working experience; OR PhD in Statistics or Biostatistics with 2+ years of experience. - Strong programming skills in R - Preferred Qualifications: - Ph.D. in Statistics or Biostatistics with 2+ years of experience as a biostatistician in the biopharmaceutical or medical diagnostics industry, academia or government (e.g., FDA, NIH) - Knowledge and experience with one or more of the following: - Clinical Study Design - Clinical Trials - Time-to event data analysis and longitudinal data analysis - Statistical Methods in Diagnostic Medicine - Clinical and analytical validation of medical diagnostic devices and/or companion diagnostics - Categorical data analysis - Missing data analysis - Real-world data (RWD) analysis - Bayesian Methods - Next Generation Sequencing (NGS) and genomics - - Leadership skills including proactive strategy setting, priority evaluations, conflict resolution, and effective cross-functional partnerships - Excellent communication, presentations and writing skills, and ability to explain complex technical details in clear language - Demonstrated ability of independent thinking - Demonstrated ability to meet project deadlines managing multiple projects simultaneously - Demonstrated record of successful independent work and contributions to team projects - High level of detail orientation with a focus on quality - Understanding of HIPPA and importance of privacy of patient data - Commitment to reflect FMI’s values: Integrity, Courage, and Passion - The expected salary range for this position based on the primary location of Remote is $125,000 - $148,000 per year. The salary range is commensurate with Foundation Medicine’s 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. #LI-Remote

Provide virtual lifestyle counseling to enhance nutrition and dietary quality, set appointments for clinical trial subjects, and collaborate with project managers to ensure timely completion of visits and documentation.

Role Description Make a Difference on Your Own Schedule and Terms! Hiring Per Diem Bilingual Registered Dietitians for Virtual Visits! Must be fluent in Spanish/English. EmVenio Research provides quality, in-home clinical trial visits for various Sponsors and CROs. We're the only company that hires, trains, certifies, tests, and manages our own Registered Dietitians. Our mission is to bring clinical trial visits to subjects wherever they may be to increase convenience and compliance with study protocols. Be part of a team who fully embrace our values and key behaviors! - We work as a team - We do the right thing - We figure it out - We pursue growth - We take ownership Why work for EmVenio? - We bring research to every neighborhood — making it more accessible, more inclusive, and more human — so every community can share in the promise of better care. - Be a member of our general staffing pool - No research experience required, on the job training provided - Gain Certification through GCP training Qualifications - Bachelor’s degree from an accredited dietetics program (If CDR examination was before January 1, 2024) - Graduate degree from an accredited dietetics program (If CDR examination was on or after January 1, 2024) - Registered Dietitian (RD) or Registered Dietitian Nutritionist (RDN) Certification by the Commission on Dietetic Registration (CDR) - Current State Dietitian License/Certification in good standing (if applicable) Requirements - Performs the full scope of Registered Dietitian practices; including, but not limited to, providing virtual lifestyle counseling visits to improve nutrition and dietary quality, mental health and developing coping skills, and building health behavior and lifestyle habits that align with participant’s goals and values. - Sets appointments with subjects within the required appointment window. - Completes virtual visits for clinical trial subjects. - Works cooperatively with Clinical Project Manager and site personnel to complete visits and submit accurate source documents in a timely manner. - Regularly stay informed on the latest nutrition and food health updates. - Performs additional duties and responsibilities as deemed necessary. Benefits - Standard Rate: $46.00 Hourly plus commute, mileage, training, and administrative pay. Contact Information Please contact Ashley Sin at (303) 317-5486 x486 or at ashley.sin@emvenio.com today to learn more about our opportunities where you can make a difference in your own career! Professional Case Management is an Equal Opportunity Employer.