Senior Biostatistician
What you need
- Master's in Statistics/Biostatistics or related field
- 6+ yrs biostatistics experience (3+ with PhD)
- Expert in clinical trial design and biostatistics processes
- Strong R programming required; Python preferred
- FDA IVD submission experience a plus
What you'll do
- Lead statistical design and analysis for complex clinical studies
- Develop protocols, SAPs, and regulatory submission documents
- Oversee statistical programming deliverables and timelines
- Communicate results via publications, presentations, and reports
- Establish and maintain biostatistics SOPs and standards
About this opportunity:
We are seeking a Senior Biostatistician to expand the Freenome Biostatistics team. This role will support statistical study design, analysis, summarization of clinical studies to support research, development and regulatory submissions for Freenome’s in vitro diagnostic products (IVDs). The ideal candidate is passionate about biostatistics and the opportunity to have a significant impact to change the landscape of early cancer detection.
This role will report to the Principal Biostatistician. This role will be a Remote role.
What you’ll do:
- 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 the study protocols, statistical analysis plans, and related documents.
- Interpreting 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 prepareing and reviewing statistical analyses, summaries, and supporting documentation in collaboration with Regulatory, Clinical, and other stakeholders.
- Support the preparation of abstracts, oral presentations, manuscripts and written reports by ensuring the results of clinical programs and studies are effectively communicated to internal and external stakeholders.
- Provide statistical expertise to internal and external stakeholders (e.g., presentation/publication, Marketing, Health Economics & Reimbursement).
- Create, maintain, and implement SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency, and optimization.
Must haves:
- Masters degree or higher in Statistics, Biostatistics, Bioinformatics, Data Science or Math.
- 6+ years of related experience with a Master's Degree; or 3+ years of related experience with a PhD; or equivalent experience
- Expert understanding of related aspects of biostatistics processes and systems.
- Excellent written and verbal communication skills including the ability to interact professionally with all organizational levels to drive achievement of deliverables.
- Strong interpersonal and relationship management skills including the ability to proactively elevate and resolve issues cross-functional to ensure project objectives are met.
- Comprehensive organizational, judgment, analytical, decision-making, and influencing skills.
- Expert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problems.
- Ability to develop effective peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
- Ability to thrive in a fast paced, dynamic, and constantly changing work environment.
- Strong programming skills using R (required) and Python (preferred). Demonstrated proficiency with literate programming (R markdown/ Sweave).
Nice to haves:
- Ph.D degree or higher in Statistics, Biostatistics or Math.
- Experience leading IVD clinical Biostatistics to FDA submission.
- Knowledge of CDISC requirements preferred.
Benefits and additional information:
The US target range of our base salary rate for new hires is $140,250 - $200,025. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.
Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Applicants have rights under Federal Employment Laws.
- Family & Medical Leave Act (FMLA)
- Equal Employment Opportunity (EEO)
- Employee Polygraph Protection Act (EPPA)
California applicants please review the CCPA Notice at Collection here:
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About Freenome
Freenome is a high-growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease. To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas. We have raised more than $1.1 billion from leading investors like Perceptive Advisors, RA Capital Management, Roche Venture Fund, Kaiser Permanente, Novartis and the American Cancer Society’s BrightEdge Ventures. A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career.
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