Freenome

Clinical Research

• Perform in a lead Biostatistician role and provide technical expertise as a core team member of high complexity clinical studies, including statistical oversight and attending relevant project meetings.
• Provide advanced statistical guidance and thought leadership for innovative study design and clinical development plans, including endpoint selection, estimands, sample size and power, and analysis methods.
• Develop the statistical sections of study protocols, statistical analysis plans, and related documents.
• Interpret analysis results and conduct the overall statistical review of tables, figures, and listings to ensure accurate and consistent reporting in study reports and regulatory documents.
• Partner with statistical programmers to establish priorities, manage timelines, review deliverable quality, and resolve issues affecting project objectives.
• Support regulatory submissions and responses by preparing and reviewing statistical analyses, summaries, and supporting documentation with Regulatory, Clinical, and other stakeholders.
• Support preparation of abstracts, oral presentations, manuscripts, and written reports.
• Provide statistical expertise to internal and external stakeholders, including presentation/publication, Marketing, and Health Economics & Reimbursement.
• Create, maintain, and implement biostatistics SOPs, processes, standards, and work instructions.

Senior Biostatistician

Technical Product Manager

• Plan and coordinate execution of engineering initiatives for the Commercial Data Platform and Data Products.
• Create, plan, and execute software development plans while ensuring efficiency, scalability, and usability.
• Gather requirements and prioritize technical development with cross-functional teams and stakeholders.
• Lead discussions with key decision-makers and stakeholders to create a comprehensive data platform roadmap.
• Work closely with engineering using Agile methodologies, including Scrum, Kanban, and sprint planning.
• Define requirements and manage development processes, systems, and software infrastructure for data platforms and tools.
• Partner with laboratory and business stakeholders to elucidate requirements, optimize workflows, and lead data platform and product definition aligned with HIPAA and HITECH.
• Translate product requirements into Epics and Stories with clear user acceptance criteria.
• Track and drive development using an issue tracking system such as Jira.
• Facilitate interactions between users and engineers to ensure user needs are understood and met.
• Create and operationalize technical strategy and integrated roadmaps for data products, pipelines, and tooling.
• Align cross-functional milestones and deliverables across current and future programs.
• Provide a vision for future development focused on scalability and accessibility.
• Ensure data integrity throughout the pipeline using technical and process-oriented solutions.
• Report to the Associate Director, Technical Product Management.

Technical Product Manager III

General Counsel

• Provide practical, business-oriented legal support for Freenome's clinical, commercial, research, technology and strategic partnership priorities
• Draft, review and negotiate commercial, vendor, professional services, technology, software, data, confidentiality and strategic collaboration agreements
• Advise on contract structure and risk allocation, including liability, indemnification, insurance, intellectual property, publications, data security, payment and termination terms
• Support strategic partnerships, commercialization initiatives, health-system collaborations and other business-critical programs
• Draft and negotiate clinical trial and site agreements, amendments, material transfer agreements, research and collaboration agreements, business associate agreements and data-sharing terms
• Partner with Clinical, Corporate Development, Commercial, Finance and other stakeholders on scopes, budgets, payment terms, specimen use, publication rights and intellectual property provisions
• Identify and address healthcare, privacy and compliance issues, including HIPAA and data-security requirements
• Prepare and maintain amendments and templates reflecting entity changes, assignments, study updates, new workstreams and agreed business terms
• Drive agreements from issue spotting and redlines through signature routing, execution confirmation and delivery of fully executed agreements
• Maintain matter status in the contract lifecycle management system from intake through closeout
• Coordinate signature workflows, approvals and signature authority, and maintain executed agreement records
• Improve templates, fallback language, playbooks and intake processes
• Provide status updates, surface dependencies and communicate legal recommendations to business partners and legal leadership
• Assess material legal risks, develop workable compromises and escalate significant issues appropriately
• Counsel stakeholders on confidentiality, publications, privacy, data security, insurance and intellectual property
• Collaborate with senior legal team members, subject-matter experts and outside counsel while retaining day-to-day ownership
• Report to the Director, Corporate Counsel