Senior Biostatistician

Freenome

. 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.

Posted 9/24/2026full-timeRemote • United StatesSenior💰 $140,250 - $200,025 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates advanced statistical expertise in clinical study design, including endpoint selection, sample size determination, and analysis methods. Proficient in statistical programming with R and Python, with a strong focus on regulatory submissions and cross-functional collaboration.

Highest-signal resume keywords

Biostatistics ExpertiseStatistical Programming in RClinical Trial DesignRegulatory Submission SupportInterpersonal Relationship Management

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Hard Skills

Statistical AnalysisStudy Protocol DevelopmentStatistical ReviewSample Size CalculationData Interpretation

Soft Skills

Excellent Communication SkillsProblem-SolvingOrganizational SkillsDecision-MakingInfluencing Skills

Tools & Technologies

RPythonR MarkdownSweave

Certifications & Qualifications

Masters Degree in StatisticsPhD in Statistics (Nice to Have)

Industry Keywords

Clinical StudiesCDISC RequirementsIVD Clinical BiostatisticsRegulatory DocumentsHealth Economics & Reimbursement

Tech Stack

Tools & technologies

Python

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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).
Ph.D degree or higher in Statistics, Biostatistics or Math (nice to have).
Experience leading IVD clinical Biostatistics to FDA submission (nice to have).
Knowledge of CDISC requirements preferred.

Benefits

Comp & perks

Equity
Cash bonuses
Full range of medical, financial, and other benefits
Equal-opportunity employer and diversity commitment