Senior Biostatistician New

Freenome; United States; Remote; USD 140,000 - 200,000; Full time

Benefits offered by this job

Equity

Bonus opportunity

Medical benefits

Flexible remote work

Job summary

Freenome is seeking a Senior Biostatistician to expand the Biostatistics team. This remote role supports study design, analysis, and regulatory submissions for Freenome’s IVD products with potential to impact early cancer detection.

You will report to the Principal Biostatistician and collaborate across departments to create robust statistical plans and reporting for clinical programs.

Qualifications

• Master’s degree or higher in Statistics, Biostatistics, Bioinformatics, Data Science or Math.
• 6+ years of related experience with a Master’s; or 3+ years with a PhD; or equivalent experience.
• Expert understanding of biostatistics processes and systems.
• Excellent written and verbal communication across organizational levels.
• Strong interpersonal and relationship management for cross-functional collaboration.
• Comprehensive organizational, analytical, decision-making, and influencing skills.
• Expert understanding of clinical trial design and application of methodologies.
• Ability to develop cross-functional relationships to maximize best practice sharing.
• Ability to thrive in a fast-paced, dynamic work environment.
• Strong programming using R (required) and Python (preferred).

Responsibilities

• Lead Biostatistician role in high complexity clinical studies; provide technical expertise and attend project meetings.
• Provide advanced statistical guidance for study design, endpoints, estimands, sample size and power, and analysis methods.
• Develop statistical sections of protocols, SAPs, and related documents.
• Interpret analysis results and oversee reporting in study reports and regulatory documents.
• Collaborate with statistical programmers to prioritize work and ensure timely deliverables.
• Support regulatory submissions by preparing and reviewing statistical analyses and summaries.
• Assist in abstracts, presentations, manuscripts and reports for internal and external stakeholders.
• Provide statistical expertise to stakeholders (e.g., publications, marketing, health economics).
• Create and maintain SOPs and processes to ensure compliance and efficiency.

Skills

R programming

Python

Biostatistics

Study design

Regulatory submissions

Education

Master’s degree in Statistics/Biostatistics/Bioinformatics/Data Science/Math

PhD in Statistics/Biostatistics/Math

Job description

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.

California applicants please review the CCPA Notice at Collection here:

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Freenome’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

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